CompletedNot Applicable

SCP Hip Outcomes Study

United States77 participantsStarted 2018-03-27

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Surgeon considers the patient appropriate for the SCP Procedure of the hip.
✓. Subchondral bone defect(s) in the femoral head, femoral neck and/or acetabulum has been confirmed via radiographic finding on MRI or x-ray.
✓. Subject provides voluntary signature on the IRB approved Informed Consent Form.
✓. Subject is at least 18 years of age.
✓. Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol and complete outcome forms via email, telephone, in-person or by regular mail.

Exclusion criteria

✕. Subject has collapse of subchondral bone.
✕. Subject is pregnant at the time of surgery.
✕. Subject is incarcerated.
✕. Subject is involved in active litigation related to the condition being treated.
✕. Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.

What they're measuring

Overall Group Mean Improvement From Baseline of the Modified Harris Hip Score (mHHS) at 2 Years

Timeframe: 2 Years

Trial details

NCT IDNCT03494660

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-10-23

Results submitted2026-01-15

View on ClinicalTrials.gov More Subchondral Cysts trials