SCP-EMEA-01
Research type
Research Study
Full title
Prospective Post-Market Data Collection on Patients with Bone Marrow Lesions in the Knee Treated with Subchondroplasty procedure
IRAS ID
233774
Contact name
David Duffy
Contact email
Sponsor organisation
Zimmer Biomet
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 11 months, 1 days
Research summary
This is a prospective, multi-center, post-market data collection study intended to collect data on the short- and long term safety and performance of the Subchondroplasty (SCP) Procedure. The SCP procedure is developed to treat patients with Bone Marrow Lesions (BMLs). BMLs are subchondral bone defects that may lead to pain and loss of function of the joint. This study will focus on BMLs in the knee. \n\nEvery patient undergoing the SCP Procedure in one of the study sites will be invited to participate in the study. The study goal is to collect data for up to 250 patients and evaluate demographics and outcomes data. Subjects will be followed through 5 years with assessments at 1 month, 3 months, 6 months, 1 year and annually thereafter. All subjects will complete patient questionnaires. The investigative center will perform a knee examination (till 12 month follow-up visit only), collect medication and therapy use and if applicable complete AE forms. \n\nThe primary endpoint will be change in pain from baseline to 12 months following the SCP Procedure, as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale. Secondary objectives include documenting clinical outcomes such as pain, function of daily living, function of sports and recreation, and other knee related quality of life measures following a SCP Procedure. Other secondary objectives include evaluating subject global satisfaction, healthcare resource utilization and the safety profile by determining AEs, surgical complications occurring from the time of surgery and the incidence and time to subsequent secondary surgical intervention including re-operation and revision. For a subset of approximately 100 consecutive subjects at selected centers, X-ray and MRI variables will be evaluated.
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0046
Date of REC Opinion
17 Apr 2019
REC opinion
Further Information Favourable Opinion