CompletedNot Applicable

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

United States294 participantsStarted 2018-08-31

Plain-language 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

Who can participate

Age range13 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Clinical Success Rate, Defined as Participant Joints Without Reintervention at 6 Months Post-operative, as Assessed by the Surgeon

Timeframe: 6 months

Trial details

NCT IDNCT03594071

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-12-11

Results submitted2020-12-01

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