SCP® Observational Study of the Knee
- Conditions
- Bone Marrow Edema
- Registration Number
- NCT03110224
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
Post Market clinical outcomes study to collect data on the short - and long-term outcomes for subjects who are undergoing or who have undergone the Subchondroplasty (SCP) Procedure in the knee in a standard clinical setting. Outcomes to be assessed include pain medication usage, pain, function, activity levels and patient satisfaction.
- Detailed Description
This is a post-market, multi-center, patient outcomes centered study to evaluate the on-label use of AccuFill during the Subchondroplasty procedure. Enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one Bone Marrow Lesion (BML) in the knee. Demographics, medical history and medications will recorded at the time of enrollment. Surgical details including the SCP procedure, concomitant surgical procedures and intraoperative safety events will be recorded. Subjects will complete patient reported outcomes measures pre-operatively including the Visual Analog Scale (VAS) for knee pain, International Knee Documentation Committee Subject Knee (IKDC) Form and the Veterans Rand 12 (VR-12) Item Health Survey. These measures will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. Screening for adverse events and revision surgeries will occur throughout the study.
Target enrollment is 1000 subjects at up to 30 clinical sites. Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 516
- Surgeon considers patient appropriate for SCP procedure.
- Patient has agreed to undergo the SCP procedure or has already undergone the procedure.
- Subject is willing and able to sign a written consent form.
- The subject has the mental capacity and the willingness to contribute follow-up outcome data.
- Patient is willing and able to complete outcome forms in person or by phone, email or regular mail.
- Patient is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline Visual Analog Scale (VAS) Pain Scale at 12 months 12 months Change from baseline score of pain intensity at 12 months.
- Secondary Outcome Measures
Name Time Method Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations 5 years Summary and description of procedure and device related adverse events and surgical re-operations and relatedness to the bone substitute material and procedure
Trial Locations
- Locations (14)
OrthoIndy
🇺🇸Indianapolis, Indiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beaumont Health System
🇺🇸Royal Oak, Michigan, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Allegheny Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Jordan-Young Institute
🇺🇸Virginia Beach, Virginia, United States
Orthopaedic Surgical Associates
🇺🇸North Chelmsford, Massachusetts, United States
Associated Orthopedists
🇺🇸Saint Clair Shores, Michigan, United States
Foundation for Orthopaedic Research and Education (FORE)
🇺🇸Tampa, Florida, United States
Southern Ortho
🇺🇸Johns Creek, Georgia, United States
Cascio Sports Medicine
🇺🇸Lake Charles, Louisiana, United States
New York University School of Medicine
🇺🇸Huntington Station, New York, United States
Denver-Vail Orthopedics
🇺🇸Parker, Colorado, United States
Atlantis Orthopaedics
🇺🇸Palm Beach Gardens, Florida, United States