SCP® Observational Study of the Knee
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03110224 |
Recruitment Status :
Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : April 1, 2020
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Condition or disease | Intervention/treatment |
---|---|
Bone Marrow Edema | Device: Subchondroplasty Procedure with AccuFill |
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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Other |
Target Follow-Up Duration: | 5 Years |
Official Title: | Zimmer Knee Creations SCP® Observational Cohort Follow-Up Study |
Actual Study Start Date : | September 18, 2012 |
Estimated Primary Completion Date : | December 31, 2020 |
Estimated Study Completion Date : | December 31, 2022 |
- 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 knee(Subchondroplasty (SCP) Procedure).
- Change from baseline Visual Analog Scale (VAS) Pain Scale at 12 months [ Time Frame: 12 months ]Change from baseline score of pain intensity at 12 months.
- Incidence and severity of device and/or procedure related adverse events and re-visions/re-operations [ Time Frame: 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. Patient is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.

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): NCT03110224
United States, Colorado | |
Denver-Vail Orthopedics | |
Parker, Colorado, United States, 80134 | |
United States, Florida | |
Atlantis Orthopaedics | |
Palm Beach Gardens, Florida, United States, 33410 | |
Foundation for Orthopaedic Research and Education (FORE) | |
Tampa, Florida, United States, 33637 | |
United States, Georgia | |
Southern Ortho | |
Johns Creek, Georgia, United States, 30097 | |
United States, Indiana | |
OrthoIndy | |
Indianapolis, Indiana, United States, 46143 | |
United States, Louisiana | |
Cascio Sports Medicine | |
Lake Charles, Louisiana, United States, 70601 | |
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Orthopaedic Surgical Associates | |
North Chelmsford, Massachusetts, United States, 01863 | |
United States, Michigan | |
Beaumont Health System | |
Royal Oak, Michigan, United States, 48073 | |
Associated Orthopedists | |
Saint Clair Shores, Michigan, United States, 48080 | |
United States, New York | |
New York University School of Medicine | |
Huntington Station, New York, United States, 11746 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43221 | |
United States, Pennsylvania | |
Allegheny Singer Research Institute | |
Pittsburgh, Pennsylvania, United States, 15212 | |
United States, Virginia | |
Jordan-Young Institute | |
Virginia Beach, Virginia, United States, 23462 |
Study Director: | Lynsey Boyle, BS | Zimmer Biomet |
Responsible Party: | Zimmer Biomet |
ClinicalTrials.gov Identifier: | NCT03110224 |
Other Study ID Numbers: |
KC.CR.I.AM.16.3 |
First Posted: | April 12, 2017 Key Record Dates |
Last Update Posted: | April 1, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Subchondroplasty Bone Marrow Lesion Arthroscopy |
Bone Substitute Material AccuFill Subchondral Bone Defect |