SCP Hip Outcomes Study

Completed

Conditions studied: Subchondral Cysts, Subchondral Bone Edema, Bone Marrow Edema, Insufficiency Fractures, Avascular Necrosis of Hip, Femoroacetabular Impingement, Dysplasia; Hip

In brief

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.

Key facts

Study ID

NCT03494660

Run by

Zimmer Biomet

People needed

77

Starts

2018-03-27

Expected to finish

2025-01-13

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidates must meet ALL of the following:
• 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.

You may not qualify if…

• Candidates will be excluded if they meet ANY of the following:
• 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.

Where it is running

• Eisenhower Desert Orthopedic Center — Rancho Mirage, California, United States
• Andrews Research & Education Foundation — Gulf Breeze, Florida, United States
• OrthoIllinois — Rockford, Illinois, United States
• University of Kentucky Research Foundation — Lexington, Kentucky, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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