---
title: S&P of Q-Fix™ All-Suture Anchor System
nct_id: NCT03594071
overall_status: COMPLETED
sponsor: Smith & Nephew, Inc.
study_type: OBSERVATIONAL
primary_condition: Bankart Lesion
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03594071.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03594071"
ct_last_update_post_date: 2021-02-09
last_seen_at: "2026-05-12T06:34:08.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# S&P of Q-Fix™ All-Suture Anchor System

**Official Title:** Safety and Performance of Q-Fix™ All-Suture Anchor System

**NCT ID:** [NCT03594071](https://clinicaltrials.gov/study/NCT03594071)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 294
- **Lead Sponsor:** Smith & Nephew, Inc.
- **Conditions:** Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion, Acromioclavicular Sprain, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, Bicep Tendinitis, Extra-capsular Repair, Medial Collateral Ligament, Lateal Collateral Ligament, Posterior Oblique Ligament, IBT, Vastus Medialis, Obliquus Advancement, Joint Capsule Closure
- **Start Date:** 2018-08-31
- **Completion Date:** 2019-12-11
- **CT.gov Last Update:** 2021-02-09

## 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

## Eligibility

- **Minimum age:** 13 Years
- **Sex:** ALL
- **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.
```

## Interventions

- **The Q-Fix™ All-Suture Anchor** (DEVICE) — Observational, post-market, clinical follow-up study

## Primary Outcomes

- **Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon** _(time frame: 6 months)_ — All individuals for whom the outcome of re-intervention is known at 6 months

## Secondary Outcomes

- **Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon** _(time frame: 12 months)_
- **Hip Visual Analog Scale (VAS) - Pain** _(time frame: Screening, 6 months, and 12 months)_
- **Knee Visual Analog Scale (VAS) - Pain** _(time frame: Screening, 6 months, and 12 months)_
- **Shoulder Visual Analog Scale (VAS) - Pain** _(time frame: Screening, 6 months, and 12 months)_
- **Hip Range of Motion (ROM)** _(time frame: Screening, 6 months, and 12 months)_
- **Knee Range of Motion (ROM)** _(time frame: Screening, 6 months, and 12 months)_
- **Shoulder Range of Motion (ROM)** _(time frame: Screening, 6 months, and 12 months)_

## Locations (5)

- The Orthopaedic Center- Center for Advanced Orthopaedics, Washington D.C., District of Columbia, United States
- Northshore University Health System, Chicago, Illinois, United States
- Tulane University Medical Center /Tulane Institute of Sport Medicine, New Orleans, Louisiana, United States
- Oklahoma Sports and Orthopedics Institute, Oklahoma City, Oklahoma, United States
- Palmetto Health USC Orthopedic Center, Columbia, South Carolina, United States

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the orthopaedic center- center for advanced orthopaedics|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `locations.northshore university health system|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.tulane university medical center /tulane institute of sport medicine|new orleans|louisiana|united states` — added _(2026-05-12)_
- `locations.oklahoma sports and orthopedics institute|oklahoma city|oklahoma|united states` — added _(2026-05-12)_
- `locations.palmetto health usc orthopedic center|columbia|south carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03594071.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03594071*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*