Bone Marrow EdemaSCPNCT01621893
Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions
An observational study of Bone Marrow Edema, run by Zimmer Biomet at 6 sites in United States.
Trial summary
Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty procedure including changes in pain, function, and overall health. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Bone Marrow Edema
- What is being tested?
- Subchondroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 Mar 2012to 26 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
CORE Orthopaedics
Encinitas, California, 92024
Steadman Hawkins Foundation
Greenville, South Carolina, 29615
Hinsdale Orthopedics
New Lenox, Illinois, 60451
Hospital for Joint Disease
New York, New York, 10003
Rothman Institute
Philadelphia, Pennsylvania, 19107
Allegheny Orthopaedic Associates
Pittsburgh, Pennsylvania, 15212
About this study
Official title: Prospective Efficacy Evaluation of Subchondroplasty™ for the Treatment of Defects Associated With Tibial Bone Marrow Lesions
Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty procedure including changes in pain, function, and overall health.
Read the detailed description
This study is designed as a prospective, consecutive series outcomes study. Patients presenting with knee pain associated with bone marrow lesions that meet the inclusion criteria will be eligible to undergo Subchondroplasty procedure. The subjects will be followed for twenty-four (24) months after surgery via office visits and will be contacted once per year for up to 5 years post-operatively and asked questions regarding their pain and functioning to further understand long-term outcomes.. Seventy (70), a ( minimum of sixty-two (62)) patients who meet the inclusion/exclusion criteria will be enrolled in the study. Up to 5 sites will participate in this study. The study is intended to provide an estimate of one-year and two-year clinical success with minimum bias and with sufficient statistical precision to permit meaningful comparison to commonly accepted two-year clinical success rates for currently available treatment alternatives. An improvement of 10 points on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscore on the KOOS Scoring System from baseline to 1-year post-operative is considered minimal perceptible clinical improvement and will be used to define the primary clinical success criterion for this study.
- Conditions
- Bone Marrow Edema
- Being tested
- Subchondroplasty
- Keywords
- bone marrow edema, bone marrow defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SubchondroplastyProcedure or surgery
Also called Calcium Phosphate Bone substitute filling of micro fractures
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Subchondroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 Year
Secondary outcomes (6)
Improvement from baseline in KOOS subsection scores
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.
Measured: 24 Months
Improvement in VAS
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.
Measured: 24 Months
Improvement in Modified Knee Score
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
Measured: 24 Months
Improvement in IKDC
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.
Measured: 24 Months
Maintenance or improvement in usage (i.e., reduction in usage) of NSAIDs, narcotics, anti-inflammatory medications
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
Measured: 24 Months
Complications or secondary procedures at index site of knee
Incidence of secondary or revision procedures will be recorded
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study start26 Mar 2012
- Primary completion17 Jan 2018
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Marrow EdemaStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Cohen, MD, Principal investigator, Rothman Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621893
- Sponsor's protocol ID
- KC-SCP-001
- Acronym
- SCP
- Status last verified
- Sep 2021
- First submitted
- 14 Jun 2012
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39667406
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Efficacy Evaluation of Subchondroplasty™ for the Treatment of Defects Associated With Tibial Bone Marrow Lesions
- ClinicalTrials.gov ID
- NCT01621893
- Acronym / sponsor ID
- SCP / KC-SCP-001
- Conditions
- Bone Marrow Edema
- Keywords
- bone marrow edema, bone marrow defects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2012 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty procedure including changes in pain, function, and overall health.
Detailed description
This study is designed as a prospective, consecutive series outcomes study. Patients presenting with knee pain associated with bone marrow lesions that meet the inclusion criteria will be eligible to undergo Subchondroplasty procedure. The subjects will be followed for twenty-four (24) months after surgery via office visits and will be contacted once per year for up to 5 years post-operatively and asked questions regarding their pain and functioning to further understand long-term outcomes.. Seventy (70), a ( minimum of sixty-two (62)) patients who meet the inclusion/exclusion criteria will be enrolled in the study. Up to 5 sites will participate in this study. The study is intended to provide an estimate of one-year and two-year clinical success with minimum bias and with sufficient statistical precision to permit meaningful comparison to commonly accepted two-year clinical success rates for currently available treatment alternatives. An improvement of 10 points on the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscore on the KOOS Scoring System from baseline to 1-year post-operative is considered minimal perceptible clinical improvement and will be used to define the primary clinical success criterion for this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BML of the Knee | – | Procedure: SubchondroplastySubject 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SubchondroplastyAlso: Calcium Phosphate Bone substitute filling of micro fractures | Procedure or surgery | BML of the Knee |
Primary outcome
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
6 secondary outcomes
Improvement from baseline in KOOS subsection scores
Time frame: 24 Months
Improvement in VAS
Time frame: 24 Months
Improvement in Modified Knee Score
Time frame: 24 Months
Improvement in IKDC
Time frame: 24 Months
Maintenance or improvement in usage (i.e., reduction in usage) of NSAIDs, narcotics, anti-inflammatory medications
Time frame: 24 Months
Complications or secondary procedures at index site of knee
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Derived from this study: PubMed 39667406Cohen 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.
- Individual participant dataSharing planned: No
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Cohen, MD principal investigator
Rothman Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Edema, run by Zimmer Biomet at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury Osteoarthritis Outcomes Score (KOOS) Pain Subscore (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01621893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.