Use of Demineralised Bone Matrix (DBX) in Osteochondritis Dissecans (OCD)

Study Overview
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Brief Summary
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This is a 1:1 randomised pilot study in 30 patients in 1 site in Helsinki, Finland. The investigators hypothesize that function, pain, type and quality of cartilage in adult patients with osteochondritis dissecans of the knee will be better in the DBX group compared to the mosaicplasty group.

Official Title
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A Randomized, Subject-blind, Controlled Pilot Trial to Evaluate the Effectiveness and Safety of the Use of Demineralized Bone Matrix (DBX®) Versus Mosaicplasty in the Treatment of Late-Stage Osteochondritis Dissecans (OCD) of the Knee in Patients With a Mature Skeleton

Conditions
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Osteochondritis Dissecans

Intervention / Treatment
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* Device: DBX Putty
* Procedure: Mosaicplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, age between 18 years and 65 years Females of childbearing potential must have a negative serum or urine pregnancy test at the time of inclusion Females of childbearing potential must be willing to use effective means of birth control for at least 1 year post surgery. Medically acceptable contraceptives include: Surgical sterilisation Approved hormonal contraceptives Barriers methods combined with a spermicide An intrauterine device Abstinence alone is not considered an acceptable method of contraception Late stage Osteochondritis Dissecans (ICD-10 code M93.2) of the knee classified as stage III or IV (Anderson MRI classification) Mature skeleton Written informed consent prior to any study specific procedures (except the procedures necessary to determine eligibility) Ability and willingness to comply with all study specific procedures, including attending all follow-up visits up to 12 months postoperative and completing questionnaires in a local language Exclusion Criteria: More than 1 knee affected Patients who can be treated with conservative treatment alone, unless there is evidence of at least 6 months failed previous treatment Systemic disease including AIDS, HIV, Hepatitis or any other disease that would prevent normal organ and marrow function. Patients undergoing systemic cortisone treatment or immunosuppressive therapy (e.g. avascular necrosis) Patients undergoing active cancer therapy (chemotherapy, radiation treatment). History of alcohol abuse or illegal drug use. Participation in any other device or drug trial within 3 months prior to the inclusion in the study Presence of at least one contraindication for DBX® Putty

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBX<br>DBX Putty in glass syringe | Device: DBX Putty<br>* OCD of the knee will be treated with DBX Putty<br>|
| Active Comparator: Mosaicplasty<br> | Procedure: Mosaicplasty<br>* Mosaicplasty procedure performed to treat OCD of the knee<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Brittberg-Peterson functional assessment score from baseline until 12 months post-op | Score 0-130 (see Clin Orthop Relat Res 2000 May;374:212-34) to assess function and pain | At enrollment (day -7), at full weight-bearing (6-8 weeks post-operative), 6 months post-operative, 12 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type and quality of the formed cartilage to assess the effectiveness of the treatment | The type and quality of the newly formed cartilage will be assessed with arthroscopy and/or MRI /dGEMRIC) | 12 months post-operative | 
| Number of patients with complications to assess the safety of the use of the treatment | All adverse events and complications will be recorded throughout the trial and assessed for severity and causality. | Enrolment (day -7) until 12 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteochondritis Dissecans, OCD, Mosaicplasty, Demineralised Bone Matrix, DBX, DBX Putty