Osteochondritis DissecansPhase 4NCT01283737
Use of Demineralised Bone Matrix (DBX) in Osteochondritis Dissecans (OCD)
A Phase 4 study testing DBX Putty and Mosaicplasty in people with Osteochondritis Dissecans, run by Synthes GmbH at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteochondritis Dissecans
- What is being tested?
- DBX Putty and Mosaicplasty
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- DBX Putty, Mosaicplasty
- Keywords
- Osteochondritis Dissecans, OCD, Mosaicplasty, Demineralised Bone Matrix, DBX, DBX Putty
- Medical subject headings
- Osteochondritis Dissecans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBX PuttyDevice
OCD of the knee will be treated with DBX Putty
MosaicplastyProcedure or surgery
Mosaicplasty procedure performed to treat OCD of the knee
| Study group | Role | What they receive |
|---|---|---|
| DBX | Experimental | DBX Putty in glass syringe Receives: Device: DBX Putty |
| Mosaicplasty | Active comparator | Not described Receives: Procedure: Mosaicplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The type and quality of the newly formed cartilage will be assessed with arthroscopy and/or MRI /dGEMRIC)
Measured: 12 months post-operative
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.
Measured: Enrolment (day -7) until 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondritis DissecansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthes GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jari Salo, MD, Principal investigator, Töölö Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283737
- Sponsor's protocol ID
- STU-BIO-T-XX-001-01
- Status last verified
- Jun 2012
- First submitted
- 28 May 2010
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01283737
- Acronym / sponsor ID
- STU-BIO-T-XX-001-01
- Conditions
- Osteochondritis Dissecans
- Keywords
- Osteochondritis Dissecans, OCD, Mosaicplasty, Demineralised Bone Matrix, DBX, DBX Putty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Synthes GmbHIndustry (pharma, biotech, devices)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBX | Experimental | Device: DBX PuttyDBX Putty in glass syringe |
| Mosaicplasty | Active comparator | Procedure: Mosaicplasty |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBX PuttyOCD of the knee will be treated with DBX Putty | Device | DBX |
| MosaicplastyMosaicplasty procedure performed to treat OCD of the knee | Procedure or surgery | Mosaicplasty |
Primary outcome
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
2 secondary outcomes
Type and quality of the formed cartilage to assess the effectiveness of the treatment
Time frame: 12 months post-operative
Number of patients with complications to assess the safety of the use of the treatment
Time frame: Enrolment (day -7) until 12 months post-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jari Salo, MD principal investigator
Töölö Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DBX Putty and Mosaicplasty in people with Osteochondritis Dissecans, run by Synthes GmbH at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.