- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03494660
SCP Hip Outcomes Study
A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed as a post-market, single arm, non-randomized multi-center investigation.
Male and female subjects, at least 18 years of age, with at least one subchondral bone defect in the form of a cyst and/or bone marrow lesion (BML), insufficiency fracture or bone defect associated with early stage avascular osteonecrosis (AVN) in the femoral head, femoral neck and/or acetabulum who are suitable candidates for use of AccuFill during the Subchondroplasty Procedure are eligible for enrollment in this study.
A maximum of 15 study sites, in the United States of America, will enroll a target of 50 subjects.
Each Investigator must obtain IRB approval, or favorable opinion by an EC, prior to consent of the first subject; no study-related procedures can occur without the approval and oversight of a registered IRB or EC. If the study site does not have an IRB of record, a central IRB may be utilized upon approval by Zimmer Biomet.
Demographics, medical history, hip history and use of pain medication and therapy will be recorded at the time of subject consent. Additionally, patient reported outcomes measures will be obtained pre-operatively. Operative details including the SCP Procedure, concomitant surgical procedures and intraoperative safety events will be recorded at the time of surgery. Prospective subjects will be considered enrolled in this study once their Subchondroplasty Procedure has been performed.
Subjects will complete only the Numeric Pain Scale at 2 weeks post-operatively. Thereafter, subjects will complete self-reported outcomes measures post-operatively at 6 weeks, 12 weeks, 6 months, 1 year and 2 years. These measures include information on pain medication and therapy, pain levels, function, activity and subject satisfaction. Screening for adverse events and conversion will occur throughout the study.
Subjects will complete the study at 2 years or will be withdrawn if they undergo conversion of the Subchondroplasty site. For the purposes of this protocol, a conversion will be defined as total hip arthroplasty or any procedure involving removal of the AccuFill material on the index hip.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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California
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Rancho Mirage, California, United States, 92270
- Eisenhower Desert Orthopedic Center
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Florida
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Gulf Breeze, Florida, United States, 32561
- Andrews Research & Education Foundation
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Illinois
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Rockford, Illinois, United States, 61114
- OrthoIllinois
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Kentucky
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Lexington, Kentucky, United States, 40506
- University of Kentucky Research Foundation
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, United States, 43202
- The Ohio State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Modified Harris Hip Score (mHHS) from baseline at 12 months
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in numeric pain score from baseline at 12 months
Time Frame: 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
|
Change in Hip Outcome Score from baseline at 12 months
Time Frame: 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
|
Change in EuroQol-5 Dimensions (EQ-5D) from baseline at 12 months
Time Frame: 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.
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12 months
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Incidence and severity of device and/or procedure related adverse events and surgical conversions
Time Frame: 2 years
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Summary and description of procedure and device related adverse events and surgical conversions and relatedness to the bone substitute material and procedure
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSU2017-03KC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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