Tibial NonunionsNCT00679328
OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions
A study testing Surgical implantation of OP-1 device or autograft bone graft material in people with Tibial Nonunions, run by Olympus Biotech Corporation at 18 sites in United States.
Trial summary
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tibial Nonunions
- What is being tested?
- Surgical implantation of OP-1 device or autograft bone graft material
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 1992to Dec 1999
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must show radiographic skeletal maturity
- Documented evidence of previous fracture management
- Nonunion in the tibia and candidate to receive bone autografts and intramedullary (IM) Nail fixation
- Nonunion gap must not exceed half the diameter of the bone at the site of fracture, as assessed radiographically prior to study treatment
Who cannot join
- Patients who do not have adequate vascularity to permit healing
- Patients with inadequate skin coverage
- Patients with chronic use of steroidal medications
- Patients with active infection systemically or at the site of nonunion.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Atlanta, Georgia
Study site
Cleveland, Ohio
Study site
Denver, Colorado
Study site
Detroit, Michigan
Study site
Fort Carson, Colorado
Study site
Galveston, Texas
Study site
Lubbock, Texas
Study site
Mesa, Arizona
Study site
Miami, Florida
Study site
Modesto, California
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
Providence, Rhode Island
Study site
San Diego, California
Study site
St Louis, Missouri
Study site
Stanford, California
About this study
Official title: Study #91-01 - A Randomized Study of the Stryker OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft.
Read the detailed description
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates) of the OP Device to that of traditional bone autografts to repair nonunions.
- Conditions
- Tibial Nonunions
- Being tested
- Surgical implantation of OP-1 device or autograft bone graft material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical implantation of OP-1 device or autograft bone graft materialDevice
Surgical implantation of OP-1 device or autograft bone graft material
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Surgical implantation of OP-1 Receives: Device: Surgical implantation of OP-1 device or autograft bone graft material |
| 2 | Active comparator | Surgical implantation of bone graft material Receives: Device: Surgical implantation of OP-1 device or autograft bone graft material |
What is being measured
The primary outcome is the main question the study is designed to answer.
No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging.
Measured: 3, 6, 9, 12, 24 months
Secondary outcomes (1)
Medical events, treatment related events, laboratory tests, medication use.
Measured: 3, 6, 9, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startFeb 1992
- Primary completionAug 1996
- Study completionDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial NonunionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Biotech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679328
- Sponsor's protocol ID
- 91-01
- Other IDs
- TR-0056
- Status last verified
- Jun 2011
- First submitted
- 13 May 2008
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study #91-01 - A Randomized Study of the Stryker OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions
- ClinicalTrials.gov ID
- NCT00679328
- Acronym / sponsor ID
- 91-01
- Conditions
- Tibial Nonunions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Olympus Biotech CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 1992
- Primary completion
- Aug 1996 (actual)
- Study completion
- Dec 1999 (actual)
- First posted
- 16 May 2008 (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 study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft.
Detailed description
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates) of the OP Device to that of traditional bone autografts to repair nonunions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Surgical implantation of OP-1 device or autograft bone graft materialSurgical implantation of OP-1 |
| 2 | Active comparator | Device: Surgical implantation of OP-1 device or autograft bone graft materialSurgical implantation of bone graft material |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must show radiographic skeletal maturity
- Documented evidence of previous fracture management
- Nonunion in the tibia and candidate to receive bone autografts and intramedullary (IM) Nail fixation
- Nonunion gap must not exceed half the diameter of the bone at the site of fracture, as assessed radiographically prior to study treatment
Key exclusion criteria (4 listed)
- Patients who do not have adequate vascularity to permit healing
- Patients with inadequate skin coverage
- Patients with chronic use of steroidal medications
- Patients with active infection systemically or at the site of nonunion.
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 |
|---|---|---|
| Surgical implantation of OP-1 device or autograft bone graft materialSurgical implantation of OP-1 device or autograft bone graft material | Device | 1, 2 |
Primary outcome
No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging.
Time frame: 3, 6, 9, 12, 24 months
1 secondary outcome
Medical events, treatment related events, laboratory tests, medication use.
Time frame: 3, 6, 9, 12, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical implantation of OP-1 device or autograft bone graft material in people with Tibial Nonunions, run by Olympus Biotech Corporation at 18 sites in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging. (time frame: 3, 6, 9, 12, 24 months). 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 10 Jun 2011.