SCP® Observational Study of the Knee

Zimmer Knee Creations SCP® Observational Cohort Follow-Up Study

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.

Study Overview

• Status: Terminated
• Conditions: Bone Marrow Edema
• Intervention / Treatment: Device: Subchondroplasty Procedure with AccuFill

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

• Study Type: Observational
• Enrollment (Actual): 516

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Parker, Colorado, United States, 80134
      • Denver-Vail Orthopedics
  • Florida
    • Palm Beach Gardens, Florida, United States, 33410
      • Atlantis Orthopaedics
    • Tampa, Florida, United States, 33637
      • Foundation for Orthopaedic Research and Education (FORE)
  • Georgia
    • Johns Creek, Georgia, United States, 30097
      • Southern Ortho
  • Indiana
    • Indianapolis, Indiana, United States, 46143
      • OrthoIndy
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Cascio Sports Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • North Chelmsford, Massachusetts, United States, 01863
      • Orthopaedic Surgical Associates
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health System
    • Saint Clair Shores, Michigan, United States, 48080
      • Associated Orthopedists
  • New York
    • Huntington Station, New York, United States, 11746
      • New York University School of Medicine
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Ohio State University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Singer Research Institute
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Jordan-Young Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

1. Surgeon considers patient appropriate for SCP procedure.
2. Patient has agreed to undergo the SCP procedure or has already undergone the procedure.
3. Subject is willing and able to sign a written consent form.
4. The subject has the mental capacity and the willingness to contribute follow-up outcome data.
5. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurences and Severity of Device and/or Procedure Related Adverse Events and Re-visions/Re-operations	Summary and description of procedure and device related adverse events and surgical re-operations and relatedness to the bone substitute material and procedure	5 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Charles Jaggard, Zimmer Biomet

Publications and helpful links

Helpful Links

• The Subchondroplasty® (SCP®) Procedure

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2012
• Primary Completion (Actual): September 16, 2020
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Arthroscopy; Subchondroplasty; Bone Substitute Material; Subchondral Bone Defect; AccuFill; Bone Marrow Lesion
• Other Study ID Numbers: KC.CR.I.AM.16.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes