Acetabular Labrum Tear, Acromioclavicular Sprain, Bankart Lesion, Bicep Tendinitis, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair, Extra-capsular Repair, IBT, Joint Capsule Closure, Lateal Collateral Ligament, Medial Collateral Ligament, Obliquus Advancement, Posterior Oblique Ligament, Rotator Cuff Repair, SLAP Lesion, Vastus Medialis
Conditions
Brief summary
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
Interventions
DEVICEThe Q-Fix™ All-Suture Anchor
Observational, post-market, clinical follow-up study
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject has undergone arthroscopic or open soft tissue repair with Q-Fix™ All-Suture Anchor System * Subject was ≥ 13 of age at time of surgery
Exclusion criteria
* Subject is ≤ 6 months post-operative * Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon | 6 months | All individuals for whom the outcome of re-intervention is known at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hip Visual Analog Scale (VAS) - Pain | Screening, 6 months, and 12 months | 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. |
| Knee Visual Analog Scale (VAS) - Pain | Screening, 6 months, and 12 months | 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. |
| Shoulder Visual Analog Scale (VAS) - Pain | Screening, 6 months, and 12 months | 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. |
| Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon | 12 months | All individuals for whom the outcome of re-intervention is known at 12 months |
| Knee Range of Motion (ROM) | Screening, 6 months, and 12 months | Full Range of Motion (ROM) defined as full functional arc in knee by the physician |
| Shoulder Range of Motion (ROM) | Screening, 6 months, and 12 months | Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician. |
| Hip Range of Motion (ROM) | Screening, 6 months, and 12 months | Full Range of Motion (ROM) defined as full functional arc in hip by the physician. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Safety Population All subjects enrolled into the study | 294 |
| Safety Population All subjects enrolled into the study | 309 |
| Total | 603 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Missed visit | 2 |
| Overall Study | Re-operation | 3 |
Baseline characteristics
| Characteristic | Safety Population |
|---|---|
| Age, Continuous | 37.10 years STANDARD_DEVIATION 16.6 |
| Body Mass Index | 27.39 kg/m^2 STANDARD_DEVIATION 7.06 |
| Ethnicity Hispanic/Latino | 15 Participants |
| Ethnicity Not Hispanic/Latino | 242 Participants |
| Height | 171.19 cm STANDARD_DEVIATION 11.449 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 29 Participants |
| Race/Ethnicity, Customized Other | 7 Participants |
| Race/Ethnicity, Customized Unknown | 22 Participants |
| Race/Ethnicity, Customized White | 228 Participants |
| Region of Enrollment United States | 294 participants |
| Sex: Female, Male Female | 147 Participants |
| Sex: Female, Male Male | 147 Participants |
| Weight | 177.33 pounds (lb) STANDARD_DEVIATION 46.045 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 294 |
| other Total, other adverse events | 81 / 294 |
| serious Total, serious adverse events | 22 / 294 |
Outcome results
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
Time frame: 6 months
Population: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Safety Population | Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon | 306 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
Time frame: 12 months
Population: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Safety Population | Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon | 118 joints |
Secondary
Hip Range of Motion (ROM)
Full Range of Motion (ROM) defined as full functional arc in hip by the physician.
Time frame: Screening, 6 months, and 12 months
Population: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Safety Population | Hip Range of Motion (ROM) | Hip: Screening - has full functional arc | Yes | 37 joints |
| Safety Population | Hip Range of Motion (ROM) | Hip: Screening - has full functional arc | No | 90 joints |
| Safety Population | Hip Range of Motion (ROM) | Hip: Screening - has full functional arc | Missing | 7 joints |
| Safety Population | Hip Range of Motion (ROM) | Hip: 6 months- has full functional arc | Yes | 45 joints |
| Safety Population | Hip Range of Motion (ROM) | Hip: 6 months- has full functional arc | No | 81 joints |
| Safety Population | Hip Range of Motion (ROM) | Hip: 6 months- has full functional arc | Missing | 7 joints |
| Safety Population | Hip Range of Motion (ROM) | Hip: 12 months- has full functional arc | Yes | 32 joints |
| Safety Population | Hip Range of Motion (ROM) | Hip: 12 months- has full functional arc | No | 42 joints |
| Safety Population | Hip Range of Motion (ROM) | Hip: 12 months- has full functional arc | Missing | 4 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.
Time frame: Screening, 6 months, and 12 months
Population: Per Safety Population, this includes all participants who enroll in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System i.e. subjects who only provide retrospective data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Safety Population | Hip Visual Analog Scale (VAS) - Pain | Hip: 6 months | 24.4 score on a scale | Standard Deviation 20.7 |
| Safety Population | Hip Visual Analog Scale (VAS) - Pain | Hip: 12 months | 16.3 score on a scale | Standard Deviation 18.3 |
| Safety Population | Hip Visual Analog Scale (VAS) - Pain | Hip: Screening | 51.0 score on a scale | Standard Deviation 21.7 |
Secondary
Knee Range of Motion (ROM)
Full Range of Motion (ROM) defined as full functional arc in knee by the physician
Time frame: Screening, 6 months, and 12 months
Population: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Safety Population | Knee Range of Motion (ROM) | Knee: Screening - has full functional arc | Yes | 28 joints |
| Safety Population | Knee Range of Motion (ROM) | Knee: Screening - has full functional arc | No | 14 joints |
| Safety Population | Knee Range of Motion (ROM) | Knee: Screening - has full functional arc | Missing | 15 joints |
| Safety Population | Knee Range of Motion (ROM) | Knee: 6 months- has full functional arc | Yes | 24 joints |
| Safety Population | Knee Range of Motion (ROM) | Knee: 6 months- has full functional arc | No | 25 joints |
| Safety Population | Knee Range of Motion (ROM) | Knee: 6 months- has full functional arc | Missing | 7 joints |
| Safety Population | Knee Range of Motion (ROM) | Knee: 12 months- has full functional arc | Yes | 7 joints |
| Safety Population | Knee Range of Motion (ROM) | Knee: 12 months- has full functional arc | No | 6 joints |
| Safety Population | Knee Range of Motion (ROM) | Knee: 12 months- has full functional arc | Missing | 1 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.
Time frame: Screening, 6 months, and 12 months
Population: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Safety Population | Knee Visual Analog Scale (VAS) - Pain | Knee: 6 months | 10.0 score on a scale | Standard Deviation 17.3 |
| Safety Population | Knee Visual Analog Scale (VAS) - Pain | Knee: 12 months | 23.3 score on a scale | Standard Deviation 40.4 |
| Safety Population | Knee Visual Analog Scale (VAS) - Pain | Knee: Screening | 51.3 score on a scale | Standard Deviation 25.3 |
Secondary
Shoulder Range of Motion (ROM)
Full Range of Motion (ROM) defined as full functional arc in shoulder by the physician.
Time frame: Screening, 6 months, and 12 months
Population: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Safety Population | Shoulder Range of Motion (ROM) | Shoulder: 12 months- has full functional arc | No | 16 joints |
| Safety Population | Shoulder Range of Motion (ROM) | Shoulder: 12 months- has full functional arc | Missing | 3 joints |
| Safety Population | Shoulder Range of Motion (ROM) | Shoulder: Screening - has full functional arc | Yes | 14 joints |
| Safety Population | Shoulder Range of Motion (ROM) | Shoulder: Screening - has full functional arc | No | 100 joints |
| Safety Population | Shoulder Range of Motion (ROM) | Shoulder: Screening - has full functional arc | Missing | 4 joints |
| Safety Population | Shoulder Range of Motion (ROM) | Shoulder: 6 months- has full functional arc | Yes | 24 joints |
| Safety Population | Shoulder Range of Motion (ROM) | Shoulder: 6 months- has full functional arc | No | 90 joints |
| Safety Population | Shoulder Range of Motion (ROM) | Shoulder: 6 months- has full functional arc | Missing | 1 joints |
| Safety Population | Shoulder Range of Motion (ROM) | Shoulder: 12 months- has full functional arc | Yes | 8 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.
Time frame: Screening, 6 months, and 12 months
Population: Per Safety Population, this includes all participants who enrolled in the study who had previously undergone arthroscopic repair using the Q-Fix™ All-Suture Anchor System (i.e. participants that provided retrospective data at the time frame indicated)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Safety Population | Shoulder Visual Analog Scale (VAS) - Pain | Shoulder: Screening | 53.3 score on a scale | Standard Deviation 26.4 |
| Safety Population | Shoulder Visual Analog Scale (VAS) - Pain | Shoulder: 6 months | 28.8 score on a scale | Standard Deviation 25.4 |
| Safety Population | Shoulder Visual Analog Scale (VAS) - Pain | Shoulder: 12 months | 35.6 score on a scale | Standard Deviation 27.4 |