NCT01283737
Withdrawn
Phase 4
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
ConditionsOsteochondritis Dissecans
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Osteochondritis Dissecans
- Sponsor
- Synthes GmbH
- Locations
- 1
- Primary Endpoint
- Change of Brittberg-Peterson functional assessment score from baseline until 12 months post-op
- Status
- Withdrawn
- Last Updated
- 13 years ago
Overview
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.
Investigators
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:
- •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
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
Outcomes
Primary Outcomes
Change of Brittberg-Peterson functional assessment score from baseline until 12 months post-op
Time Frame: At enrollment (day -7), at full weight-bearing (6-8 weeks post-operative), 6 months post-operative, 12 months post-operative
Score 0-130 (see Clin Orthop Relat Res 2000 May;374:212-34) to assess function and pain
Secondary Outcomes
- Number of patients with complications to assess the safety of the use of the treatment(Enrolment (day -7) until 12 months post-operative)
- Type and quality of the formed cartilage to assess the effectiveness of the treatment(12 months post-operative)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn PatientsBurnsNCT03240718Centre hospitalier de l'Université de Montréal (CHUM)12
Completed
Phase 1
Safety and Tolerability of AFFITOPE AD03Alzheimer's DiseaseNCT01309763Affiris AG28
Completed
Phase 2
MOVIPREP® Versus PICOLAX® Pilot StudyColonoscopyNCT00312481Norgine65
Active, not recruiting
Not Applicable
Pilot study, randomised, open-label, monocentre, case vs control study to assess the effect of topically and parenterally Heparin administration treatment in superficial and deep second grade burns patients. - NDSuperficial and deep second degree burns.MedDRA version: 9.1Level: LLTClassification code 10006802Term: Burns second degreeEUCTR2007-004304-12-ITAZIENDA OSPEDALIERA PISANA
Active, not recruiting
Not Applicable
Evaluation of security and efficacy of immunotherapy in HIV+ patients who suffer from grass pollen allergy.HIV+ subjects with grass pollen allergy.MedDRA version: 14.1Level: HLGTClassification code 10001708Term: Allergic conditionsSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2011-006251-11-ITAZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)