N/A
N=294
S&P of Q-Fix™ All-Suture Anchor System
Bankart Lesion · Acetabular Labrum Tear · SLAP Lesion · Acromioclavicular Sprain · Capsular Shift/Capsulolabral Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT03594071 ↗Enrolled (actual)
294
Serious AEs
7.5%
Results posted
Feb 2021
Primary outcome: Primary: Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon — 306 joints
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- The Q-Fix™ All-Suture Anchor (Device)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Smith & Nephew, Inc.
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon |
306 | — |
| SECONDARY Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon |
118 | — |
| SECONDARY Hip Visual Analog Scale (VAS) - Pain |
51.0; 24.4; 16.3 | — |
| SECONDARY Knee Visual Analog Scale (VAS) - Pain |
51.3; 10.0; 23.3 | — |
| SECONDARY Shoulder Visual Analog Scale (VAS) - Pain |
53.3; 28.8; 35.6 | — |
| SECONDARY Hip Range of Motion (ROM) |
37; 90; 7; 45; 81; 7 | — |
| SECONDARY Knee Range of Motion (ROM) |
28; 14; 15; 24; 25; 7 | — |
| SECONDARY Shoulder Range of Motion (ROM) |
14; 100; 4; 24; 90; 1 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03594071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.