SCP® Observational Study of the Knee

Bone Marrow Edema Clinical Trial

Official title:

Zimmer Knee Creations SCP® Observational Cohort Follow-Up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110224
• Other study ID #: KC.CR.I.AM.16.3
• Status: Completed
• Start date: September 18, 2012
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: May 31, 2023
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Edema

Intervention

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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Visual Analog Scale (VAS) Pain Scale at 12 months	Change from baseline score of pain intensity at 12 months.	12 months
Secondary	Incidence 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

External Links

•   The Subchondroplasty® (SCP®) Procedure