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

Primary Purpose

Osteochondritis Dissecans

Status

Withdrawn

Phase

Phase 4

Locations

Finland

Study Type

Interventional

Intervention

DBX Putty

Mosaicplasty

About this trial

This is an interventional treatment trial for Osteochondritis Dissecans focused on measuring Osteochondritis Dissecans, OCD, Mosaicplasty, Demineralised Bone Matrix, DBX, DBX Putty

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Töölö Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DBX

Mosaicplasty

Arm Description

DBX Putty in glass syringe

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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.

Full Information

NCT ID

NCT01283737

First Posted

May 28, 2010

Last Updated

June 25, 2012

Sponsor

Synthes GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01283737

Brief Title

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

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Withdrawn

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Synthes GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteochondritis Dissecans

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DBX

Arm Type

Experimental

Arm Description

DBX Putty in glass syringe

Arm Title

Mosaicplasty

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

DBX Putty

Intervention Description

OCD of the knee will be treated with DBX Putty

Intervention Type

Procedure

Intervention Name(s)

Mosaicplasty

Intervention Description

Mosaicplasty procedure performed to treat OCD of the knee

Primary Outcome Measure Information:

Title

Change of Brittberg-Peterson functional assessment score from baseline until 12 months post-op

Description

Score 0-130 (see Clin Orthop Relat Res 2000 May;374:212-34) to assess function and pain

Time Frame

At enrollment (day -7), at full weight-bearing (6-8 weeks post-operative), 6 months post-operative, 12 months post-operative

Secondary Outcome Measure Information:

Title

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

Description

The type and quality of the newly formed cartilage will be assessed with arthroscopy and/or MRI /dGEMRIC)

Time Frame

12 months post-operative

Title

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

Description

All adverse events and complications will be recorded throughout the trial and assessed for severity and causality.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jari Salo, MD

Organizational Affiliation

Töölö Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Töölö Hospital

City

Helsinki

Country

Finland

12. IPD Sharing Statement

Learn more about this trial

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

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