Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Subject has undergone arthroscopic instability repair with QFix™ All-Suture Anchor System
  • Subject was ≥ 18 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.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Retrospective

Recruiting Locations

Tulane University Medical Center /Tulane Institute of Sport Medicine
New Orleans, Louisiana 70112
Contact:
Haley Severin, MS
504-988-0653
hseverin1@tulane.edu

More Details

NCT ID
NCT03594071
Status
Recruiting
Sponsor
Smith & Nephew, Inc.

Study Contact

Kirsten Wall, MHS
1-720-338-9460
kirsten.wall@smith-nephew.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.