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| ID | Type | Description | Link |
|---|---|---|---|
| G150153 | Other Identifier | IDE Number |
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To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMPLEX | Experimental |
| |
| Autogenous Bone Graft (ABG) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMPLEX | Device | A bone graft substitute |
| |
| Autogenous Bone Graft (ABG) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint | Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 52); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52). The last observation carried forward was used for subjects with missing response status at 52 weeks. | At week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving Computerized Tomography (CT) Radiographic Fusion Success | Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion. The last observation carried forward was used for subjects with missing response status at 52 weeks. | At week 52 |
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Inclusion Criteria:
Tibiotalar (ankle); Talocalcaneal (subtalar); Talonavicular; Calcaneocuboid; Double hindfoot (e.g., talonavicular and talocalcaneal joints); Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints)
Radiographic evidence of bone defect, deficit, subsidence or subchondral cyst; More than one joint to be fused; Involvement of other adjacent or nonadjacent joints; Large surface area; Intra-articular or extra-articular deformity; Post-traumatic arthritis; Diagnosis of osteoporosis
Single hindfoot joint fusion: up to 5 cm^3; Double or triple hindfoot fusion: each individual joint up to 5 cm^3, but overall, not more than 10 cm3 for the full complement of joints; Ankle fusion: up to 10 cm^3
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physician Research Group | Gilbert | Arizona | 85295 | United States | ||
| Arizona Research Center |
A total of 80 subjects were screened in the trial, of which, 56 subjects were randomized. All the 56 randomized subjects were exposed to graft material: 39 subjects were exposed to AMPLEX and 17 subjects were exposed to autogenous bone graft (ABG).
The trial was conducted at 19 sites (14 sites in the United States and 5 sites in Canada) between July 2017 to July 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | AMPLEX | AMPLEX: A bone graft substitute |
| FG001 | Autogenous Bone Graft (ABG) | Autogenous Bone Graft (ABG): Control material administered by surgical implant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2018 | Jan 8, 2021 |
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| Procedure |
Control material administered by surgical implant |
|
| Proportion of Subjects Achieving CT Radiographic Fusion Success | Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion. | At week 12 |
| Proportion of Subjects Achieving CT Radiographic Fusion Success | Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion. | At week 24 |
| Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS) | Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure. | Baseline, and at week 12 |
| Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS) | Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure. | Baseline, and at week 24 |
| Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS) | Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure. | Baseline, and at week 52 |
| Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS) | Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure. | At week 2 |
| Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS) | Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure. | At week 6 |
| Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS) | Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure. | At week 12 |
| Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS) | Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure. | At week 24 |
| Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS) | Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure. | At week 52 |
| Change From Baseline in FAAM-ADL | Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction. | Baseline, and at week 12 |
| Change From Baseline in FAAM-ADL | Functional improvement was assessed using the e Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction. | Baseline, and at week 24 |
| Change From Baseline in FAAM-ADL | Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction. | Baseline, and at week 52 |
| Subject Performance Composite (SPC) Endpoint | Proportion of subjects who met all the following criteria for the Subject Performance Composite (SPC) endpoint at 12 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 12); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 12). | At week 12 |
| Subject Performance Composite (SPC) Endpoint | Proportion of subjects who met all the following criteria for the SPC endpoint at 24 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 24); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 24). | At week 24 |
| Change From Baseline in Short Form-12 (SF-12) | The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better. | Baseline, and at week 24 |
| Change From Baseline in Short Form-12 (SF-12) | The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better. | Baseline, and at week 52 |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| California Pacific Orthopaedics | San Francisco | California | 94118 | United States |
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | United States |
| Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| Andrews Orthopaedic and Sports Medicine Center | Gulf Breeze | Florida | 32561 | United States |
| Emory Orthopaedic and Spine Hospital | Atlanta | Georgia | 30329 | United States |
| Midwest Orthopedics at Rush | Chicago | Illinois | 60612 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Sinai Hospital of Baltimore, Inc / Rubin Institute for Advanced Orthopedics | Baltimore | Maryland | 21215 | United States |
| Medstar | Baltimore | Maryland | 21218 | United States |
| Orthopaedic Associates of Michigan, Research and Education Institute | Grand Rapids | Michigan | 49525 | United States |
| Michigan Orthopedic Center | Lansing | Michigan | 48910 | United States |
| TRIA Orthopaedic Center | Bloomington | Minnesota | 55431 | United States |
| Desert Orthopaedic Center | Las Vegas | Nevada | 89121 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Rutgers | Newark | New Jersey | 07103 | United States |
| University of Rochester School of Medicine | Rochester | New York | 14642 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| OrthoCarolina Research Institute, Inc. | Charlotte | North Carolina | 28207 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19106 | United States |
| Reconstructive Orthopaedic Associates | Philadelphia | Pennsylvania | 19107 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| Campbell Clinic Orthopaedics | Germantown | Tennessee | 38138 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0165 | United States |
| Baylor St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| University of Alberta System | Edmonton | Alberta | T6G 2B7 | Canada |
| Central Alberta Orthopedics | Red Deer | Alberta | T4N 6S4 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1Y 4E9 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5C 1R6 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| University of Laval | Québec | Quebec | G1V 4G2 | Canada |
| Modified Intention-to-treat (mITT) Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AMPLEX | AMPLEX: A bone graft substitute |
| BG001 | Autogenous Bone Graft (ABG) | Autogenous Bone Graft (ABG): Control material administered by surgical implant |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint | Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 52); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52). The last observation carried forward was used for subjects with missing response status at 52 weeks. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 52 |
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| Secondary | Proportion of Subjects Achieving Computerized Tomography (CT) Radiographic Fusion Success | Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion. The last observation carried forward was used for subjects with missing response status at 52 weeks. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 52 |
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| Secondary | Proportion of Subjects Achieving CT Radiographic Fusion Success | Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 12 |
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| Secondary | Proportion of Subjects Achieving CT Radiographic Fusion Success | Defined as ≥50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 24 |
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| Secondary | Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS) | Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | Baseline, and at week 12 |
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| Secondary | Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS) | Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | Baseline, and at week 24 |
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| Secondary | Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS) | Weight-bearing pain at the fusion site was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire. Subjects were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced, with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Improvement in pain on weight-bearing at the fusion site was defined as ≥ 20 mm reduction from baseline on 100 mm VAS, and is presented for this outcome measure. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | Baseline, and at week 52 |
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| Secondary | Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS) | Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 2 |
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| Secondary | Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS) | Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 6 |
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| Secondary | Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS) | Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 12 |
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| Secondary | Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS) | Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 24 |
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| Secondary | Proportion of Subjects With Absence of Graft Harvest Site Pain (<20 mm on 100 mm VAS) | Graft harvest site pain was assessed using a 100 mm visual analog scale (VAS), a subject self-assessment questionnaire, and was only assessed among subjects in the ABG group. Subjects in the ABG group were asked to mark the location on a 100 mm line corresponding to the amount of pain they experienced with 0 mm being "no pain" and 100 mm being "the worst pain imaginable". Absence of significant graft harvest site pain was defined as <20 mm on 100 mm VAS, and is presented for this outcome measure. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 52 |
|
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| Secondary | Change From Baseline in FAAM-ADL | Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and at week 12 |
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| Secondary | Change From Baseline in FAAM-ADL | Functional improvement was assessed using the e Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and at week 24 |
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| Secondary | Change From Baseline in FAAM-ADL | Functional improvement was assessed using the Foot and Ankle Ability Measure Activities of Daily Living (FAAM-ADL) subscale, a subject self-assessment questionnaire that consists of 21 items pertaining to basic functional activities. Each item is scored on a 5 point Likert scale anchored by 4 (no difficulty at all) and 0 (unable to do). The total item subscale score ranges from 0 to 84, which are transformed to a scale of 0 to 100 as the final score. Higher scores represent a higher level of function, with 100 representing no dysfunction. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and at week 52 |
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| Secondary | Subject Performance Composite (SPC) Endpoint | Proportion of subjects who met all the following criteria for the Subject Performance Composite (SPC) endpoint at 12 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 12); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 12). | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 12 |
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| Secondary | Subject Performance Composite (SPC) Endpoint | Proportion of subjects who met all the following criteria for the SPC endpoint at 24 weeks: 1. Improvement in pain on weight-bearing at fusion site (≥20 mm reduction from baseline on 100 mm visual analog scale [VAS]); 2. Absence of significant graft harvest site pain (<20 mm on 100 mm VAS); 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥8 points improvement from baseline); 4. Absence of device related or procedure related serious adverse events (up to week 24); 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 24). | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Number | percentage of subjects | At week 24 |
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| Secondary | Change From Baseline in Short Form-12 (SF-12) | The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and at week 24 |
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| Secondary | Change From Baseline in Short Form-12 (SF-12) | The Short Form-12 (SF-12) Health Survey includes 12 questions from the SF-36 Health Survey. These include: 2 questions concerning physical functioning; 2 questions on role limitations because of physical health problems; 1 question on bodily pain; 1 question on general health perceptions; 1 question on vitality (energy/fatigue); 1 question on social functioning; 2 questions on role limitations because of emotional problems; and 2 questions on general mental health (psychological distress and psychological well-being). These eight domain scales were used to derive Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. All scores were calculated through scoring software. Domain scales and component summary scores ranged from 0 to 100, with a higher score considered better. | The mITT analysis set comprised all randomized subjects who had an attempted fusion of the index joint(s). Subjects were analyzed according to randomized (planned) treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, and at week 52 |
|
From the signing of the informed consent up to 78 weeks
A treatment-emergent AE was any AE occurring after the initiation of the surgery. If the timing of an AE could not be established in relation to the initiation of the surgery, it was considered as a treatment-emergent AE. Only treatment-emergent AEs are presented.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMPLEX | AMPLEX: A bone graft substitute | 0 | 39 | 7 | 39 | 27 | 39 |
| EG001 | Autogenous Bone Graft (ABG) | Autogenous Bone Graft (ABG): Control material administered by surgical implant | 0 | 17 | 7 | 17 | 12 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Implant site irritation | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Incision site hypoaesthesia | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Incision site swelling | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Eschar | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | -+1 833-548-1402 | DK0-Disclosure@ferring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 27, 2017 | Jan 8, 2021 | SAP_001.pdf |
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Canada |
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