Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions

NCT01621893 | Completed DMC

• 1 other identifier: KC-SCP-001
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 6

Brief Summary

Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty procedure including changes in pain, function, and overall health.

Conditions

Bone Marrow Edema

Keywords

bone marrow edema; bone marrow defects

Outcome Measures

Primary Outcomes (1)

• Knee Injury Osteoarthritis Outcomes Score (KOOS) Pain Subscore

  Post-operative KOOS pain subsection score at 1-Year follow-up is improved by at least 10 points. The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, function in daily living, function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale

  1 Year

Secondary Outcomes (6)

• Improvement from baseline in KOOS subsection scores

  24 Months

• Improvement in VAS

  24 Months

• Improvement in Modified Knee Score

  24 Months

• Improvement in IKDC

  24 Months

• Maintenance or improvement in usage (i.e., reduction in usage) of NSAIDs, narcotics, anti-inflammatory medications

  24 Months

Study Arms (1)

BML of the Knee

Subject has single bone marrow lesion of tibia, single BML of femur, or adjoining BML's of tibia \& femur on which a Subchondroplasty procedure is performed

Procedure: Subchondroplasty

Interventions

Subchondroplasty PROCEDURE

Also known as: Calcium Phosphate Bone substitute filling of micro fractures

BML of the Knee

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with single bone marrow edema of the tibia, single bone marrow lesion of the femur or adjoining bone marrow lesions of the tibia and femur (kissing lesions).

You may qualify if:

• Subject is 40-70 of age and skeletally mature
• Subject BMI is \< 40
• Subject has experienced pain in knee for at least 3 months
• BML is confirmed on T2 weighted MR Imaging by presence of white signal
• Subject has single BML of tibia, single BML of femur, or adjoining BML's of tibia \& femur
• Baseline KOOS pain subscore is ≤65
• Subject's involved knee alignment is defined radiographically as one of the following: Neutral, ≤ to 7 degrees mechanical varus or \< 7.5 degrees mechanical valgus
• Subject's ACL and PCL ligaments are intact
• Subject has failed no more than one operative treatment on treatment knee, and none within 6 months prior to enrollment
• Subject is willing and able to sign a written consent form
• The subject has the mental capacity and the willingness to comply with the specified follow-up evaluations, and can be contacted by telephone by the site personnel.

You may not qualify if:

• Surgeon deems subject's pain to be primarily related to an alternate condition such as a baker cyst, synovitis, meniscal pathology, or other
• BML caused by acute trauma
• Subject is not neurologically intact (sensory, motor, and reflex deficit)
• Subject is insulin dependent
• Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years
• Subject with primary bone tumor in the knee area
• Subject anticipates having a lower extremity surgery other than the investigational surgery during the course of the study
• Subject has a history of substance abuse
• Subject is currently involved in another study or have received investigational product or treatment within the last 30 days
• Subject is pregnant or planning on becoming pregnant during the study period
• Subject is accepting workers' compensation

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (6)

CORE Orthopaedics

Encinitas, California, 92024, United States

Location

Hinsdale Orthopedics

New Lenox, Illinois, 60451, United States

Location

Hospital for Joint Disease

New York, New York, 10003, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny Orthopaedic Associates

Pittsburgh, Pennsylvania, 15212, United States

Location

Steadman Hawkins Foundation

Greenville, South Carolina, 29615, United States

Location

Related Publications (1)

• Cohen SB, Hajnik C, Loren GJ, Akhavan S, DeMeo PJ, Wyland DJ, Youm T, Jazrawi LM, Daley RJ, Farr J, Reischling P, Woodell-May JE. Prospective Evaluation of Clinical Outcomes of the Subchondroplasty Procedure for Treatment of Symptomatic Bone Marrow Lesions of the Knee. J Knee Surg. 2025 May;38(6):290-299. doi: 10.1055/a-2501-0910. Epub 2024 Dec 12.

  PMID: 39667406 DERIVED

Study Officials

• Steven Cohen, MD

  Rothman Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 18, 2012
• Study Start: March 26, 2012
• Primary Completion: January 17, 2018
• Study Completion: May 26, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)