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

NCT01283737 | Withdrawn Phase 4

• 1 other identifier: STU-BIO-T-XX-001-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteochondritis Dissecans

Keywords

Osteochondritis Dissecans; OCD; Mosaicplasty; Demineralised Bone Matrix; DBX; DBX Putty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Type and quality of the formed cartilage to assess the effectiveness of the treatment

  12 months post-operative

• Number of patients with complications to assess the safety of the use of the treatment

  Enrolment (day -7) until 12 months post-operative

Study Arms (2)

DBX

EXPERIMENTAL

DBX Putty in glass syringe

Device: DBX Putty

Mosaicplasty

ACTIVE COMPARATOR

Procedure: Mosaicplasty

Interventions

DBX Putty DEVICE

OCD of the knee will be treated with DBX Putty

DBX

Mosaicplasty PROCEDURE

Mosaicplasty procedure performed to treat OCD of the knee

Mosaicplasty

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, age between 18 years and 65 years
• 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

You may not qualify if:

• 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.
• Presence of at least one contraindication for DBX® Putty

Sponsors & Collaborators

• Synthes GmbH: lead

Study Sites (1)

Töölö Hospital

Helsinki, Finland

Location

MeSH Terms

Conditions

Osteochondritis Dissecans

Condition Hierarchy (Ancestors)

Osteochondritis; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Jari Salo, MD

  Töölö Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: January 26, 2011
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

FI (1)