Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Subjects will complete the study at 2 years or will be withdrawn if they undergo conversion of the Subchondroplasty site.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 Design


Related Conditions & MeSH terms


NCT number NCT03494660
Study type Observational
Source Zimmer Biomet
Contact
Status Active, not recruiting
Phase
Start date March 27, 2018
Completion date December 2025

See also
  Status Clinical Trial Phase
Completed NCT01623843 - Femoroacetabular Impingement RandomiSed Controlled Trial N/A
Completed NCT03669471 - Muscular and Functional Performance in FAIS Patients
Not yet recruiting NCT05031390 - the Horsens Aarhus FemoroAcetabular Impingement Syndrome Training Pilot Study N/A
Active, not recruiting NCT05025956 - Senolytic Agent Improve the Benefit of Platelet-Rich Plasma and Losartan Phase 1/Phase 2
Withdrawn NCT02674113 - Regional Anesthesia in Hip Arthroscopy N/A
Withdrawn NCT02260726 - Evaluation of Ultrasound for Detecting Hip Impingement N/A
Recruiting NCT05391204 - Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls N/A
Active, not recruiting NCT03891563 - Prospective Evaluation of Sport Activity and the Development of Femoroacetabular Impingement in the Adolescent Hip
Active, not recruiting NCT04069507 - Healthy Hip Study: Conservative Management for Pre-arthritic Hip Disorders
Terminated NCT03278353 - Fulfillment of Expectations for Patients With FAI Syndrome N/A
Terminated NCT03995290 - 3D Modeling to Improve Hip Arthroscopy Outcomes
Completed NCT06082271 - Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy N/A
Recruiting NCT01621360 - Hip Arthroscopy Versus Conservative Management of Femoroacetabular Impingement N/A
Completed NCT04980209 - The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping
Enrolling by invitation NCT04988659 - Analysis of Gene Expression in Femoroacetabular Impingement (FAI)
Active, not recruiting NCT04822571 - Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males N/A
Withdrawn NCT02706756 - Conservative Intervention of Femoroacetabular Impingement Syndrome N/A
Completed NCT02702661 - PRCT of FICB vs LAI for Hip Arthroscopy N/A
Completed NCT01993615 - A Physical Therapy Program Versus Surgery for Femoroacetabular Impingement: Randomized Clinical Trial N/A
Completed NCT01814124 - Conservative Management of Femoroacetabular Impingement N/A