SCP® Observational Study of the Knee

• ClinicalTrials.gov Identifier: NCT03110224
• Recruitment Status: Active, not recruiting
• First Posted: April 12, 2017
• Last Update Posted: September 9, 2019
• Sponsor: Zimmer Biomet
• Information provided by (Responsible Party): Zimmer Biomet

Study Description

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.

Condition or disease
Bone Marrow Edema

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.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

• 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

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• 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

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).

Criteria

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Zimmer Biomet

Investigators

• Study Director: Patrick Reischling, MBS; Zimmer Knee Creations, Inc.

More Information

Additional Information:

The Subchondroplasty® (SCP®) Procedure 

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT03110224
• Other Study ID Numbers: KC.CR.I.AM.16.3
• First Posted: April 12, 2017
• Last Update Posted: September 9, 2019
• Last Verified: September 2019

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: No

Keywords provided by Zimmer Biomet:

Subchondroplasty; Bone Marrow Lesion; Arthroscopy; Bone Substitute Material; AccuFill; Subchondral Bone Defect