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Safety and performance of the study devices in extremities up to 12 months post-surgery
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL | Device | PEEK Suture Anchors, which include:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention | Clinical success was defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention | Clinical success was defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) - Pain | The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain and a score of 10 indicates extreme/unbearable pain. The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery. | 6 and 12 months |
| Count of Participants With Range of Motion (ROM) Full Functional Arc |
Inclusion Criteria:
Exclusion Criteria:
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Subjects who have undergone extremity joint repair using the study devices, PEEK Anchors (DYNOMITE, SPYROMITE, RAPTOMITE, FOOTPRINT Ultra PK SL)
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| Name | Affiliation | Role |
|---|---|---|
| Judth Horner | Smith & Nephew, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States | ||
| Precision Orthopaedic Specialties, Inc. |
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It was intended to enroll participants for 4 PEEK suture anchor devices; however, no participants were enrolled in the SPYROMITE™ 2.0 PK Suture Anchor with Needles group, resulting in 3 suture anchor groups being analyzed. A total of 140 participants were enrolled in the study and 142 joints were observed. Multiple devices were implanted in 2 participants. Separate "arms" not created as participants had the same procedure on the same joint. Anchors are shown by categories (rows) throughout.
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| ID | Title | Description |
|---|---|---|
| FG000 | Polyetheretherketone (PEEK) Extremity Suture Anchors | Participants who have received Polyetheretherketone (PEEK) Extremity Suture Anchors, which included: DYNOMITE™ 2.0 PK Suture Anchor with Needles, RAPTORMITE™ 3.0 Suture Anchor with Needles, FOOTPRINT™ Ultra PK SL Suture Anchor |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2018 |
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| 12 months |
Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits. |
| 6 and 12 months |
| Chardon |
| Ohio |
| 44024 |
| United States |
| Foot and Ankle Associates of North Texas-Grapevine | Grapevine | Texas | 76051 | United States |
| Fowler Kennedy Sport Medicine Clinic | London | Ontario | N6A 3K7 | Canada |
| DYNOMITE™ 2.0 PK Suture Anchor With Needles | Type of suture anchor received at start |
|
| RAPTORMITE™ 3.0 Suture Anchor With Needles | Type of suture anchor received at start |
|
| FOOTPRINT™ Ultra PK SL Suture Anchor | Type of suture anchor received at start |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants enrolled in the study who had previously undergone extremity repair using PEEK suture anchors (i.e., retrospective data). The type(s) of PEEK anchor used during surgery was surgeon decision on a case by case basis. Multiple anchor types could be used in one surgery if required. 2 participants had multiple devices implanted. Participants with bilateral surgeries had both surgeries recorded independently. Device data analyzed individually dependent on unique suture anchor implanted.
| ID | Title | Description |
|---|---|---|
| BG000 | Polyetheretherketone (PEEK) Extremity Suture Anchors | Participants who have received Polyetheretherketone (PEEK) Extremity Suture Anchors, which included: DYNOMITE™ 2.0 PK Suture Anchor with Needles, RAPTORMITE™ 3.0 Suture Anchor with Needles, FOOTPRINT™ Ultra PK SL Suture Anchor |
| Units | Counts |
|---|---|
| Participants |
|
| joints |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | joints |
|
| |||||||||||||||||||
| Sex: Female, Male | Count of Units | joints | joints |
|
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Units | joints | joints |
|
| ||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Units | joints | joints |
|
| ||||||||||||||||||||
| Location of Device Implantation | Location of device implantation indicated as left, right, or bilaterally (i.e., both left & right). | Count of Units | joints | joints |
|
| |||||||||||||||||||
| Duration of Surgery (min) | Data only available for 102 participants due to the retrospective nature of the study. | Mean | Standard Deviation | minutes | Participants |
|
| ||||||||||||||||||
| Duration of time from injury to surgery (days) | Data only available for 87 participants due to the retrospective nature of the study. | Mean | Standard Deviation | days | Participants |
|
| ||||||||||||||||||
| Number of Joints Treated by Indication | Count of Units | joints | joints |
|
| ||||||||||||||||||||
| Disposition of Suture Anchors | Count of participants by unique PEEK Suture Anchors implanted. | Information provided based on the unique device implanted. Out of 140 overall participants, 2 were implanted with multiple Suture Anchors (devices). | Count of Participants | Participants | Participants |
|
| 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 | Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 6 Months After Intervention | Clinical success was defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
| Participants analyzed at time frame specified for each row indicates participant provided retrospective data. Some participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on specific device implanted (i.e., participants with multiple devices analyzed by unique suture anchor). Anchors shown by rows/categories as the same procedure occurred on the same joint. Overall number of participants analyzed shows combined total of distinct participants assessed. | Posted | Count of Participants | Participants | 6 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Success of the Study Devices in the Extremity Over a Time Period of 12 Months After Intervention | Clinical success was defined as extremity repairs without signs of device failure and/or re-intervention as assessed by the surgeon. Specifically, clinical success was considered "Yes" based on the following 3 main criteria:
| Participants analyzed at time frame specified for each row indicates participant provided retrospective data. Some participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on specific device implanted (i.e., participants with multiple devices analyzed by unique suture anchor). Anchors shown by rows/categories as the same procedure occurred on the same joint. Overall number of participants analyzed shows combined total of distinct participants assessed. | Posted | Count of Participants | Participants | 12 months |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Visual Analog Scale (VAS) - Pain | The VAS pain score is presented on a scale ranging from 0 to 10. A score of 0 represents no pain and a score of 10 indicates extreme/unbearable pain. The VAS rating was recorded retrospectively, per standard of care at 6 and 12 months post-surgery. | Participants analyzed at time frame specified for each row indicates participant provided retrospective data. Some participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on specific device implanted (i.e., participants with multiple devices analyzed by unique suture anchor). Anchors shown by rows/categories as the same procedure occurred on the same joint. Overall number of participants analyzed shows combined total of distinct participants assessed. | Posted | Mean | Standard Deviation | score on a scale | 6 and 12 months |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Count of Participants With Range of Motion (ROM) Full Functional Arc | Range of motion defined as the participant having a full functional arc "Yes" or "No" at 6 month and 12 month post-operative visits. | Participants analyzed at time frame specified for each row indicates participant provided retrospective data. Some participants implanted with multiple Suture Anchors (devices). Data analyzed independently based on specific device implanted (i.e., participants with multiple devices analyzed by unique suture anchor). Anchors shown by rows/categories as the same procedure occurred on the same joint. Overall number of participants analyzed shows combined total of distinct participants assessed. | Posted | Count of Participants | Participants | 6 and 12 months |
|
|
Surgery to End of Study (EOS) visit, approximately 12 months
AE reporting was collected retrospectively from the information available in the participant's medical records. A total of 140 participants were enrolled in the study. However, there were 2 participants with multiple devices implanted. Participant Suture Anchor data was analyzed independently based on the device implanted (i.e., participants implanted with multiple devices were analyzed individually based on unique suture anchor).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DYNOMITE™ 2.0 PK Suture Anchor With Needles | Participants who have received DYNOMITE™ 2.0 PK Suture Anchor with Needles | 0 | 17 | 0 | 17 | 5 | 17 |
| EG001 | RAPTORMITE™ 3.0 Suture Anchor With Needles | Participants who have received RAPTORMITE™ 3.0 Suture Anchor with Needles | 0 | 71 | 2 | 71 | 0 | 71 |
| EG002 | FOOTPRINT™ Ultra PK SL Suture Anchor | Participants who have received FOOTPRINT™ Ultra PK SL Suture Anchor | 0 | 57 | 2 | 57 | 2 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SURAL NERVE DAMAGE AND MONONEUROPATHY/PAIN SYNDROME FROM POPLITEAL ANESTHETIC BLOCK. | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| HOSPITALIZATION FOR UTI, ACUTE RENAL FAILURE, SEPSIS | Infections and infestations | Non-systematic Assessment | Unrelated to device |
| |
| COMPLEX REGIONAL PAIN SYNDROME | General disorders | Non-systematic Assessment | Definitely related to device |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEFT ACHILLES CHRONIC PAIN | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| DEHISCENCE WOUND | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| PAIN OVER LATERAL ASPECT OF LEFT ANKLE (ONGOING AT 6 MONTHS). | General disorders | Non-systematic Assessment | Unlikely related to device |
| |
| PAIN OVER LATERAL ASPECT OF LEFT ANKLE AT 6 MONTHS | General disorders | Non-systematic Assessment | Possibly related to device |
| |
| SUPERFICIAL YEAST INFECTION | Infections and infestations | Non-systematic Assessment | Unlikely related to device |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | Non-systematic Assessment | Unrelated to device |
| |
| FALL DOWN ON LEFT HEEL | Injury, poisoning and procedural complications | Non-systematic Assessment | Unrelated to device |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Judith Horner | Smtih + Nephew, Inc | +44 1482 673251 | Judith.horner@smith-nephew.com |
| Nov 12, 2021 |
| Prot_SAP_000.pdf |
| Title | Measurements |
|---|
| Female |
|
| Male |
|
| Title | Measurements |
|---|
| Hispanic or Latino |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
| No |
|
| Yes |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
|
|
|
| Title | Measurements |
|---|---|
|
| Achilles tendon |
|
| Midfoot |
|
| Metatarsal ligament |
|
| Other |
|
| Medial instability & Achilles tendon |
|
| Medial instability & Other |
|
| Midfoot & Metatarsal ligament |
|
| Metatarsal ligament & Other |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| DYNOMITE™ 2.0 PK Suture Anchor with Needles |
| |||||
| RAPTORMITE™ 3.0 PK Suture Anchor with Needles |
| |||||
| FOOTPRINT™ Ultra PK SL Suture Anchor |
|
| RAPTORMITE™ 3.0 PK Suture Anchor with Needles |
|
|
| FOOTPRINT™ ULTRA PK SL SUTURE ANCHOR |
|
|
| Participants |
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