Study Stopped
Enrollment of 500 subjects was met and Sponsor decided to discontinue enrollment as of July 2018. Sponsor believes enrollment number will provide us with sufficient follow-up to submit a substantial manuscript with minimum of 2 year follow-up data.
SCP® Observational Study of the Knee
Zimmer Knee Creations SCP® Observational Cohort Follow-Up Study
1 other identifier
observational
516
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2012
CompletedFirst Submitted
Initial submission to the registry
March 28, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedResults Posted
Study results publicly available
August 27, 2025
CompletedOctober 28, 2025
December 1, 2024
8 years
March 28, 2017
December 30, 2024
October 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline Visual Analog Scale (VAS) Pain Scale at 12 Months
Change from baseline score of pain intensity at 12 months. To collect VAS, patients marked a slash on a 10 cm horizontal line, with 0 cm indicating "no pain" and 10 cm indicating "worst possible pain." The distance from the left end of the line to the patient's mark was measured by the administrator in centimeters. Lower numbers were representative of lower pain levels.
12 months
Secondary Outcomes (1)
Occurences and Severity of Device and/or Procedure Related Adverse Events and Re-visions/Re-operations
5 years
Interventions
Injection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the knee(Subchondroplasty (SCP) Procedure).
Eligibility Criteria
The SCP Observational Cohort Study will enroll either patients undergoing SCP or patients who have already had the SCP procedure for the treatment of BMLs where bone void filler is placed at the site of the BML (defect).
You may qualify if:
- 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.
You may not qualify if:
- \. Patient is not comfortable with speaking, reading, and understanding questions and providing responses in an available language for the PROs in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (14)
Denver-Vail Orthopedics
Parker, Colorado, 80134, United States
Atlantis Orthopaedics
Palm Beach Gardens, Florida, 33410, United States
Foundation for Orthopaedic Research and Education (FORE)
Tampa, Florida, 33637, United States
Southern Ortho
Johns Creek, Georgia, 30097, United States
OrthoIndy
Indianapolis, Indiana, 46143, United States
Cascio Sports Medicine
Lake Charles, Louisiana, 70601, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Orthopaedic Surgical Associates
North Chelmsford, Massachusetts, 01863, United States
Beaumont Health System
Royal Oak, Michigan, 48073, United States
Associated Orthopedists
Saint Clair Shores, Michigan, 48080, United States
New York University School of Medicine
Huntington Station, New York, 11746, United States
Ohio State University
Columbus, Ohio, 43221, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
Jordan-Young Institute
Virginia Beach, Virginia, 23462, United States
Related Links
Limitations and Caveats
Follow-up compliance: Fewer than half of enrolled participants completed follow-up at or beyond 2 years.
Results Point of Contact
- Title
- Annette Tieu
- Organization
- Zimmer Biomet
Study Officials
- STUDY DIRECTOR
Charles Jaggard
Zimmer Biomet
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2017
First Posted
April 12, 2017
Study Start
September 18, 2012
Primary Completion
September 16, 2020
Study Completion
May 31, 2023
Last Updated
October 28, 2025
Results First Posted
August 27, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share