Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions (SCP)
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ClinicalTrials.gov Identifier: NCT01621893 |
Recruitment Status :
Completed
First Posted : June 18, 2012
Last Update Posted : September 24, 2021
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Condition or disease | Intervention/treatment |
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Bone Marrow Edema | Procedure: Subchondroplasty |
Study Type : | Observational |
Actual Enrollment : | 70 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Prospective Efficacy Evaluation of Subchondroplasty™ for the Treatment of Defects Associated With Tibial Bone Marrow Lesions |
Actual Study Start Date : | March 26, 2012 |
Actual Primary Completion Date : | January 17, 2018 |
Actual Study Completion Date : | May 26, 2021 |
Group/Cohort | Intervention/treatment |
---|---|
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
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Procedure: Subchondroplasty
Other Name: Calcium Phosphate Bone substitute filling of micro fractures |
- Knee Injury Osteoarthritis Outcomes Score (KOOS) Pain Subscore [ Time Frame: 1 Year ]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
- Improvement from baseline in KOOS subsection scores [ Time Frame: 24 Months ]The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, activities of daily living (ADL), function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale.
- Improvement in VAS [ Time Frame: 24 Months ]The VAS is a validated pain scale. Subjects are asked to rate the amount of pain they have experienced with activity (walking, climbing stairs) for the past week by placing a slash through a 100mm line, which bests describes the pain when 0 is no pain and 100 is worst pain imaginable. Study personnel will measure where the subject placed the mark and transcribe this on an eCRF.
- Improvement in Modified Knee Score [ Time Frame: 24 Months ]Subjects will be asked to complete the Modified Knee Score pre-operatively and at each follow-up visit. The Modified Knee Score is a validated questionnaire composed of 4 questions to evaluate pain and function primarily before and after knee arthroplasty. The score is based on a maximum 100 points with Excellent = 85-100; Good = 70-84; Fair = 60-69; Poor = <60
- Improvement in IKDC [ Time Frame: 24 Months ]The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. A score of zero is the lowest level of function or highest level of symptoms to 100, highest level of function and lowest level of symptoms.
- Maintenance or improvement in usage (i.e., reduction in usage) of NSAIDs, narcotics, anti-inflammatory medications [ Time Frame: 24 Months ]Subjects will be asked pre-operatively what medications are taken as part of their knee treatment and at each follow-up visit, medications taken or currently taking as part of their recovery
- Complications or secondary procedures at index site of knee [ Time Frame: 24 Months ]Incidence of secondary or revision procedures will be recorded

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621893
United States, California | |
CORE Orthopaedics | |
Encinitas, California, United States, 92024 | |
United States, Illinois | |
Hinsdale Orthopedics | |
New Lenox, Illinois, United States, 60451 | |
United States, New York | |
Hospital for Joint Disease | |
New York, New York, United States, 10003 | |
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 | |
Allegheny Orthopaedic Associates | |
Pittsburgh, Pennsylvania, United States, 15212 | |
United States, South Carolina | |
Steadman Hawkins Foundation | |
Greenville, South Carolina, United States, 29615 |
Principal Investigator: | Steven Cohen, MD | Rothman Institute |
Responsible Party: | Zimmer Biomet |
ClinicalTrials.gov Identifier: | NCT01621893 |
Other Study ID Numbers: |
KC-SCP-001 |
First Posted: | June 18, 2012 Key Record Dates |
Last Update Posted: | September 24, 2021 |
Last Verified: | September 2021 |
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 |
Product Manufactured in and Exported from the U.S.: | Yes |
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