TerminatedNot Applicable

SCP® Observational Study of the Knee

Stopped: Enrollment of 500 subjects was met and Sponsor decided to discontinue enrollment as of July 2018. Sponsor believes enrollment number will provide us with sufficient follow-up to submit a substantial manuscript with minimum of 2 year follow-up data.

United States516 participantsStarted 2012-09-18

Plain-language summary

Post Market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the Subchondroplasty (SCP) Procedure in the knee in a standard clinical setting. Outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Surgeon considers patient appropriate for SCP procedure.
✓. Patient has agreed to undergo the SCP procedure or has already undergone the procedure.
✓. Subject is willing and able to sign a written consent form.
✓. The subject has the mental capacity and the willingness to contribute follow-up outcome data.
✓. Patient is willing and able to complete outcome forms in person or by phone, email or regular mail.

What they're measuring

Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 Months

Timeframe: 12 months

Trial details

NCT IDNCT03110224

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-09-16

Results submitted2024-12-30

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