SCP® Observational Study of the Knee

NCT ID: NCT03110224

Last Updated: 2025-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

516 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-18

Study Completion Date

2023-05-31

Brief Summary

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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

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Conditions

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Bone Marrow Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Jaggard

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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Denver-Vail Orthopedics

Parker, Colorado, United States

Site Status

Atlantis Orthopaedics

Palm Beach Gardens, Florida, United States

Site Status

Foundation for Orthopaedic Research and Education (FORE)

Tampa, Florida, United States

Site Status

Southern Ortho

Johns Creek, Georgia, United States

Site Status

OrthoIndy

Indianapolis, Indiana, United States

Site Status

Cascio Sports Medicine

Lake Charles, Louisiana, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Orthopaedic Surgical Associates

North Chelmsford, Massachusetts, United States

Site Status

Beaumont Health System

Royal Oak, Michigan, United States

Site Status

Associated Orthopedists

Saint Clair Shores, Michigan, United States

Site Status

New York University School of Medicine

Huntington Station, New York, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, United States

Site Status

Jordan-Young Institute

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.subchondroplasty.com

The Subchondroplasty® (SCP®) Procedure

Other Identifiers

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KC.CR.I.AM.16.3

Identifier Type: -

Identifier Source: org_study_id

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