S&P of Q-Fix™ All-Suture Anchor System

NCT03594071 | Completed Results DMC FDA Device

• 1 other identifier: 17-5010-11
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 5

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Clinical Success Rate, Defined as Participant Joints Without Reintervention at 12 Months Post-operative, as Assessed by the Surgeon

  12 months

• Hip Visual Analog Scale (VAS) - Pain

  Screening, 6 months, and 12 months

• Knee Visual Analog Scale (VAS) - Pain

  Screening, 6 months, and 12 months

• Shoulder Visual Analog Scale (VAS) - Pain

  Screening, 6 months, and 12 months

• Hip Range of Motion (ROM)

  Screening, 6 months, and 12 months

Interventions

The Q-Fix™ All-Suture Anchor DEVICE

Observational, post-market, clinical follow-up study

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

US sites

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (5)

The Orthopaedic Center- Center for Advanced Orthopaedics

Washington D.C., District of Columbia, 20037, United States

Location

Northshore University Health System

Chicago, Illinois, 60201, United States

Location

Tulane University Medical Center /Tulane Institute of Sport Medicine

New Orleans, Louisiana, 70112, United States

Location

Oklahoma Sports and Orthopedics Institute

Oklahoma City, Oklahoma, 73072, United States

Location

Palmetto Health USC Orthopedic Center

Columbia, South Carolina, 29203, United States

Location

MeSH Terms

Conditions

Bankart Lesions

Condition Hierarchy (Ancestors)

Shoulder Fractures; Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Results Point of Contact

• Title: Kirsten Wall
• Organization: Smith+Nephew, Inc.

Kirsten.wall@smith-nephew.com

720-338-9460

Study Officials

• Lisa Langone

  GBR - T. J. Smith and Nephew Limited

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 20, 2018
• Study Start: August 31, 2018
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: February 9, 2021
• Results First Posted: February 9, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)