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Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fixâ„¢ device and meet existing MDD/MEDDEV requirements
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Q-Fixâ„¢ All-Suture Anchor | Device | Observational, post-market, clinical follow-up study |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon | All individuals for whom the outcome of re-intervention is known at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon | All individuals for whom the outcome of re-intervention is known at 12 months | 12 months |
| Hip Visual Analog Scale (VAS) - Pain |
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Inclusion Criteria:
Exclusion Criteria:
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US sites
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Langone | GBR - T. J. Smith and Nephew Limited | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Orthopaedic Center- Center for Advanced Orthopaedics | Washington D.C. | District of Columbia | 20037 | United States | ||
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The study enrolled 294 subjects at 5 investigational sites in the United States. This included a total of 309 joints: 134 hips, 118 shoulders, and 57 knees.
| ID | Title | Description |
|---|---|---|
| FG000 | Safety Population | All subjects enrolled into the study |
| 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 | Sep 9, 2019 | Aug 20, 2020 |
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VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain. |
| Screening, 6 months, and 12 months |
| Knee Visual Analog Scale (VAS) - Pain | VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain. | Screening, 6 months, and 12 months |
| Shoulder Visual Analog Scale (VAS) - Pain | VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain. | Screening, 6 months, and 12 months |
| Hip Range of Motion (ROM) | Full Range of Motion (ROM) defined as full functional arc in hip by the physician. | Screening, 6 months, and 12 months |
| Knee Range of Motion (ROM) | Full Range of Motion (ROM) defined as full functional arc in knee by the physician | Screening, 6 months, and 12 months |
| Shoulder Range of Motion (ROM) | Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician. | Screening, 6 months, and 12 months |
| Northshore University Health System |
| Chicago |
| Illinois |
| 60201 |
| United States |
| Tulane University Medical Center /Tulane Institute of Sport Medicine | New Orleans | Louisiana | 70112 | United States |
| Oklahoma Sports and Orthopedics Institute | Oklahoma City | Oklahoma | 73072 | United States |
| Palmetto Health USC Orthopedic Center | Columbia | South Carolina | 29203 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Population | All subjects enrolled into the study |
| 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 | Participants |
|
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| ||||||||||||||||||||
| Region of Enrollment | Number | participants | Participants |
|
| ||||||||||||||||||||
| Height | Includes all data available for this particular measure (retrospective data) | Mean | Standard Deviation | cm | Participants |
|
| ||||||||||||||||||
| Weight | Includes all data available for this particular measure (retrospective data) | Mean | Standard Deviation | pounds (lb) | Participants |
|
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| Body Mass Index | Includes all data available for this particular measure (retrospective data) | Mean | Standard Deviation | kg/m^2 | Participants |
|
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| Ethnicity | Includes all data available for this particular measure (retrospective data) | 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 | Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon | All individuals for whom the outcome of re-intervention is known at 6 months | Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fixâ„¢ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated) | Posted | Count of Units | joints | 6 months | joints | joints |
|
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon | All individuals for whom the outcome of re-intervention is known at 12 months | Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fixâ„¢ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated) | Posted | Count of Units | joints | 12 months | joints | joints |
|
| |||||||||||||||||||||||||||
| Secondary | Hip Visual Analog Scale (VAS) - Pain | VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain. | Per Safety Population, this includes all participants who enroll in the study who had previously undergone arthroscopic repair using the Q-Fixâ„¢ All-Suture Anchor System i.e. subjects who only provide retrospective data. | Posted | Mean | Standard Deviation | score on a scale | Screening, 6 months, and 12 months | joints | joints |
|
| ||||||||||||||||||||||||||
| Secondary | Knee Visual Analog Scale (VAS) - Pain | VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain. | Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fixâ„¢ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated) | Posted | Mean | Standard Deviation | score on a scale | Screening, 6 months, and 12 months | joints | joints |
|
| ||||||||||||||||||||||||||
| Secondary | Shoulder Visual Analog Scale (VAS) - Pain | VAS scores as reported by the site were converted if required such that all data was reported on a scale of 0-100 (e.g. if the scale was 0-10, then the value was multiplied by 10). Note that VAS scores should be interpreted with caution as use of pain medications may affect the results. A higher score indicates more pain. | Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fixâ„¢ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated) | Posted | Mean | Standard Deviation | score on a scale | Screening, 6 months, and 12 months | joints | joints |
|
| ||||||||||||||||||||||||||
| Secondary | Hip Range of Motion (ROM) | Full Range of Motion (ROM) defined as full functional arc in hip by the physician. | Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fixâ„¢ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated) | Posted | Count of Units | joints | Screening, 6 months, and 12 months | joints | joints |
|
| |||||||||||||||||||||||||||
| Secondary | Knee Range of Motion (ROM) | Full Range of Motion (ROM) defined as full functional arc in knee by the physician | Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fixâ„¢ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated) | Posted | Count of Units | joints | Screening, 6 months, and 12 months | joints | joints |
|
| |||||||||||||||||||||||||||
| Secondary | Shoulder Range of Motion (ROM) | Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician. | Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fixâ„¢ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated) | Posted | Count of Units | joints | Screening, 6 months, and 12 months | joints | joints |
|
|
12 months
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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 | Safety Population | All subjects enrolled into the study | 0 | 294 | 22 | 294 | 81 | 294 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abcess of shoulder | Infections and infestations | Non-systematic Assessment | Unrelated to device |
| |
| Adhesive capsulitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Related to device |
| |
| Biceps tear/tendon rupture | Injury, poisoning and procedural complications | Non-systematic Assessment | Unrelated to device |
| |
| Biceps tear/tendon rupture | Injury, poisoning and procedural complications | Non-systematic Assessment | Possibly related to device |
| |
| Biceps tear/tendon rupture | Injury, poisoning and procedural complications | Non-systematic Assessment | Related to device |
| |
| Bone fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | Unrelated to device |
| |
| Graves disease | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Hip pain | General disorders | Non-systematic Assessment | Related to device |
| |
| Hip pain | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Incomplete healing | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Knee Arthrofibrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Labral tear | Injury, poisoning and procedural complications | Non-systematic Assessment | Unrelated to device |
| |
| Recurrent rotator cuff tear | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unrelated to device |
| |
| Removal of screw | Congenital, familial and genetic disorders | Non-systematic Assessment | Unrelated to device |
| |
| Rotator cuff and slap lesion repair | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unrelated to device |
| |
| Shoulder Arthrofibrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Spinal cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Suicidal ideation | Psychiatric disorders | Non-systematic Assessment | Unrelated to device |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Adhesive capsulitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Arm pain | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Back pain | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Clicking/popping sensation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Clicking/popping sensation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Possibly related to device |
| |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | Unrelated to device |
| |
| Discoloration of foot | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Erythema/rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Groin pain | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Groin pain | General disorders | Non-systematic Assessment | Possibly related to device |
| |
| Groin stiffness/tightness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Hematuria | Renal and urinary disorders | Non-systematic Assessment | Unrelated to device |
| |
| Hip pain | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Hip pain | General disorders | Non-systematic Assessment | Possibly related to device |
| |
| Hip stiffness/tightness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Implant pulled out of bone | Injury, poisoning and procedural complications | Non-systematic Assessment | Related to device |
| |
| Inflammation | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Unrelated to device |
| |
| Knee pain | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Leg pain | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Leg pain | General disorders | Non-systematic Assessment | Possibly related to device |
| |
| Lumbar facet arthrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Lymphedema | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Muscle strain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Numbness/weakness | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Pain | General disorders | Non-systematic Assessment | Unrelated to device |
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| Pain | General disorders | Non-systematic Assessment | Possibly related to device |
| |
| Patellar malalignment | Nervous system disorders | Non-systematic Assessment | Unrelated to device |
| |
| Recurrent shoulder instability | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unrelated to device |
| |
| Shoulder pain | General disorders | Non-systematic Assessment | Unrelated to device |
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| Shoulder pain | General disorders | Non-systematic Assessment | Possibly related to device |
| |
| Shoulder subluxation | Injury, poisoning and procedural complications | Non-systematic Assessment | Unrelated to device |
| |
| Snapping Iliopsoas Tendon | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Stiffness/tightness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to device |
| |
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment | Unrelated to device |
| |
| Withdrawal symptoms | General disorders | Non-systematic Assessment | Unrelated to device |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | Non-systematic Assessment | Unrelated to device |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Wall | Smith+Nephew, Inc. | 720-338-9460 | Kirsten.wall@smith-nephew.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 28, 2019 | Aug 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000070896 | Bankart Lesions |
| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| Title | Measurements |
|---|---|
| Female |
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| Male |
|
| Title | Measurements |
|---|---|
| White |
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| Asian |
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| Black or African American |
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| American Indian or Alaska Native |
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| Other |
|
| Unknown |
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| Title | Measurements |
|---|---|
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| joints |
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| joints |
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| joints |
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| joints |
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| joints |
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| joints |
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| joints |
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| Missing |
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| Missing |
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| Missing |
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| Missing |
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| Missing |
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| Missing |
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