Clinical trial NCT01283737: Use of Demineralised Bone Matrix (DBX) in Osteochondritis Dissecans (OCD)
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Osteochondritis Dissecans
Keywords: Osteochondritis Dissecans
OCD
Mosaicplasty
Demineralised Bone Matrix
DBX
DBX Putty
Lead sponsor: Synthes GmbH
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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:

  1. Surgical sterilisation
  2. Approved hormonal contraceptives
  3. Barriers methods combined with a spermicide
  4. An intrauterine device
  5. 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

Primary outcomes:
measure: Change of Brittberg-Peterson functional assessment score from baseline until 12 months post-op
timeFrame: At enrollment (day -7), at full weight-bearing (6-8 weeks post-operative), 6 months post-operative, 12 months post-operative
Secondary outcomes:
measure: Type and quality of the formed cartilage to assess the effectiveness of the treatment
timeFrame: 12 months post-operative
measure: Number of patients with complications to assess the safety of the use of the treatment
timeFrame: Enrolment (day -7) until 12 months post-operative
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Töölö Hospital
Study officials:
affiliation: Töölö Hospital
name: Jari Salo, MD
role: PRINCIPAL_INVESTIGATOR
References: