Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions

Completed

Conditions studied: Bone Marrow Edema

In brief

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

Key facts

Study ID

NCT01621893

Run by

Zimmer Biomet

People needed

70

Starts

2012-03-26

Expected to finish

2021-05-26

Last updated by the study team

2021-09-24

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• CORE Orthopaedics — Encinitas, California, United States
• Hinsdale Orthopedics — New Lenox, Illinois, United States
• Hospital for Joint Disease — New York, New York, United States
• Rothman Institute — Philadelphia, Pennsylvania, United States
• Allegheny Orthopaedic Associates — Pittsburgh, Pennsylvania, United States
• Steadman Hawkins Foundation — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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