Femoroacetabular Impingement Clinical Trial
Official title:
A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip
Verified date | May 2024 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 2025 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Candidates must meet ALL of the following: 1. Surgeon considers the patient appropriate for the SCP Procedure of the hip. 2. Subchondral bone defect(s) in the femoral head, femoral neck and/or acetabulum has been confirmed via radiographic finding on MRI or x-ray. 3. Subject provides voluntary signature on the IRB approved Informed Consent Form. 4. Subject is at least 18 years of age. 5. 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: - Candidates will be excluded if they meet ANY of the following: 1. Subject has collapse of subchondral bone. 2. Subject is pregnant at the time of surgery. 3. Subject is incarcerated. 4. Subject is involved in active litigation related to the condition being treated. 5. Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol. |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | The Ohio State University | Columbus | Ohio |
United States | Andrews Research & Education Foundation | Gulf Breeze | Florida |
United States | University of Kentucky Research Foundation | Lexington | Kentucky |
United States | Eisenhower Desert Orthopedic Center | Rancho Mirage | California |
United States | OrthoIllinois | Rockford | Illinois |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Modified Harris Hip Score (mHHS) from baseline at 12 months | Change in Modified Harris Hip Score using a 0-100 overall score, from baseline at 12 months. Subscales of pain, function, and activity levels are combined to generate the overall score. Pain is scored out of 44 possible points, function is scored out of 33 possible points and subject activities are scored out of 14 possible points. The maximum score of 91 is multiplied by 1.1 to give a total score out of 100; a higher score represents better patient reported pain, function and activity levels. | 12 months | |
Secondary | Incidence and severity of device and/or procedure related adverse events and surgical conversions | Summary and description of procedure and device related adverse events and surgical conversions and relatedness to the bone substitute material and procedure | 2 years | |
Secondary | Change in numeric pain score from baseline at 12 months | Change in numeric pain score using a 0-10 scale, from baseline at 12 months. Patient's current hip pain will be selected where 0 describes no pain and 10 describes worst possible pain on average over the past 24 hours. | 12 months | |
Secondary | Change in Hip Outcome Score from baseline at 12 months | Change in patient Activities of Daily Living and Sports, from baseline at 12 months.
The Activities of Daily Living (ADL) and Sports subscales are scored separately. On the ADL subscale, the score on each of the items are added together to get the item score total. The total number of items with a response is multiplied by 4 to get the highest potential score. If the subject answers all 17 items, the highest potential score is 68. If one item is not answered the highest score is 64, if two are not answered the total highest score is 60, etc. The item score total is divided by the highest potential score. This value is then multiplied by 100 to get a percentage. The Sports subscale is scored in a similar manner with the highest potential score being 36. A higher score represents a higher level of physical function for both the ADL and Sports subscales. |
12 months | |
Secondary | Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months | Change in patient quality of life from baseline at 12 months. A scoring function is created using a population preference weighted health index. | 12 months |
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