SCP Hip Outcomes Study
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|ClinicalTrials.gov Identifier: NCT03494660|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment|
|Subchondral Cysts Subchondral Bone Edema Bone Marrow Edema Insufficiency Fractures Avascular Necrosis of Hip Femoroacetabular Impingement Dysplasia; Hip||Device: Subchondroplasty Procedure with AccuFill|
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 100 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. A member of the study staff will contact subjects post-operatively at 3 years, 4 years and 5 years by telephone to verify completion of the Numeric Pain Scale and a Subject Global Satisfaction Survey. Screening for adverse events and conversion will occur throughout the study.
Subjects will complete the study at 5 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 :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||A Longitudinal Outcomes Study of the Subchondroplasty® Procedure in the Hip|
|Actual Study Start Date :||March 27, 2018|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2025|
- Device: Subchondroplasty Procedure with AccuFill
Injection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the hip (Subchondroplasty (SCP) Procedure).
- 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.
- Incidence and severity of device and/or procedure related adverse events and surgical conversions [ Time Frame: 5 years ]Summary and description of procedure and device related adverse events and surgical conversions and relatedness to the bone substitute material and procedure
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494660
|Contact: Lynsey Boyle, BSemail@example.com|
|Contact: Marianne Rahme, BAfirstname.lastname@example.org|
|United States, California|
|Eisenhower Desert Orthopedic Center||Recruiting|
|Rancho Mirage, California, United States, 92270|
|Contact: Charles Cyr email@example.com|
|Contact: Wendy Monaco firstname.lastname@example.org|
|Principal Investigator: Matthew Diltz, MD|
|United States, Illinois|
|Evanston, Illinois, United States, 60201|
|Contact: Meryem Saracoglu MSaracoglu@northshore.org|
|Contact: Abigail Warren AWarren@northshore.org|
|Principal Investigator: Patrick Birmingham, MD|
|Rockford, Illinois, United States, 61114|
|Contact: Lisa Foti, MS email@example.com|
|Contact: Sean Kampe, MS firstname.lastname@example.org|
|Principal Investigator: Geoffrey Van Thiel, MD|
|United States, Ohio|
|The Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43202|
|Contact: Angela Pedroza, MPH Angela.Pedroza@osumc.edu|
|Principal Investigator: William K Vasileff, MD|
|Sub-Investigator: John Ryan, MD|