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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBX | Experimental | DBX Putty in glass syringe |
|
| Mosaicplasty | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBX Putty | Device | OCD of the knee will be treated with DBX Putty |
| |
| 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 |
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jari Salo, MD | Töölö Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Töölö Hospital | Helsinki | Finland |
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| ID | Term |
|---|---|
| D010008 | Osteochondritis Dissecans |
| ID | Term |
|---|---|
| D010007 | Osteochondritis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Mosaicplasty |
| Procedure |
Mosaicplasty procedure performed to treat OCD of the knee |
|
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 |