Bone GraftNCT00708474
OsseoFit™ Prospective Data Collection
A study testing OsseoFit™ Porous Tissue Matrix™ in people with Bone Graft and Knee, run by Zimmer Biomet at 1 site in United States.
Trial summary
This study compares the fill of bone graft sites in the knee. It is hypothesized that harvest sites, voids, and defects caused by trauma that are treated with the OsseoFit™ Porous Tissue Matrix™ device will achieve a better fill grade than those treated with the conventional method. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bone Graft, Knee
- What is being tested?
- OsseoFit™ Porous Tissue Matrix™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Feb 2009
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The OsseoFit™ Porous Tissue Matrix™ is intended to be gently packed into the bony voids or gaps of the extremities and pelvis caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from repetitive motion or traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device is a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood, platelets, or bone marrow aspirate. The addition of these autogenous blood products does not compromise the performance of the device. Hydration with biologically beneficial sterile fluids can potentially have a positive influence on the healing and replacement of the device with bone.
Who cannot join
- Infection at site
- Hypercalcemia
- Known allergies to bovine collagen
- Current osteomyelitis at operative site
- Systemic conditions which affect bone and/or wound healing
- Known severe allergies manifested by history of anaphylaxis
- Desensitization treatment injections to meat products, as injections may contain bovine collagen
- Severe degenerative bone disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection
This study compares the fill of bone graft sites in the knee. It is hypothesized that harvest sites, voids, and defects caused by trauma that are treated with the OsseoFit™ Porous Tissue Matrix™ device will achieve a better fill grade than those treated with the conventional method.
- Conditions
- Bone Graft, Knee
- Being tested
- OsseoFit™ Porous Tissue Matrix™
- Keywords
- Bone graft, Bone void filler, Bone plug, OsseoFit™, knee, bone graft sites in the knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseoFit™ Porous Tissue Matrix™Device
Bone void filler
| Study group | Role | What they receive |
|---|---|---|
| OsseoFit™ | Experimental | Treatment of bone graft site with OsseoFit™ Porous Tissue Matrix™. Receives: Device: OsseoFit™ Porous Tissue Matrix™ |
| Open | No intervention | Treatment of bone graft site without OsseoFit™ Porous Tissue Matrix™. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Site repair grade by MRI analysis
Measured: 6 months
Secondary outcomes (5)
Site repair grade by MRI analysis
Measured: 3 months, 1 year
Pain Score
Measured: 3 months, 6 months, 1 year
Function Score
Measured: 3 months, 6 months, 1 year
Physical Evaluation
Measured: 3 months, 6 months, 1 year
Incidence of adverse events
Measured: Any time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
Why it stopped: Planning new study protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone GraftStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard C Lehman, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708474
- Sponsor's protocol ID
- BSM2008001
- Status last verified
- Jan 2019
- First submitted
- 25 Jun 2008
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection
- ClinicalTrials.gov ID
- NCT00708474
- Acronym / sponsor ID
- BSM2008001
- Conditions
- Bone Graft, Knee
- Keywords
- Bone graft, Bone void filler, Bone plug, OsseoFit™, knee, bone graft sites in the knee
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Planning new study protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 2 Jul 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 compares the fill of bone graft sites in the knee. It is hypothesized that harvest sites, voids, and defects caused by trauma that are treated with the OsseoFit™ Porous Tissue Matrix™ device will achieve a better fill grade than those treated with the conventional method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OsseoFit™ | Experimental | Device: OsseoFit™ Porous Tissue Matrix™Treatment of bone graft site with OsseoFit™ Porous Tissue Matrix™. |
| Open | No intervention | –Treatment of bone graft site without OsseoFit™ Porous Tissue Matrix™. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The OsseoFit™ Porous Tissue Matrix™ is intended to be gently packed into the bony voids or gaps of the extremities and pelvis caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from repetitive motion or traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device is a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood, platelets, or bone marrow aspirate. The addition of these autogenous blood products does not compromise the performance of the device. Hydration with biologically beneficial sterile fluids can potentially have a positive influence on the healing and replacement of the device with bone.
Key exclusion criteria (8 listed)
- Infection at site
- Hypercalcemia
- Known allergies to bovine collagen
- Current osteomyelitis at operative site
- Systemic conditions which affect bone and/or wound healing
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 |
|---|---|---|
| OsseoFit™ Porous Tissue Matrix™Bone void filler | Device | OsseoFit™ |
Primary outcome
Site repair grade by MRI analysis
Time frame: 6 months
5 secondary outcomes
Site repair grade by MRI analysis
Time frame: 3 months, 1 year
Pain Score
Time frame: 3 months, 6 months, 1 year
Function Score
Time frame: 3 months, 6 months, 1 year
Physical Evaluation
Time frame: 3 months, 6 months, 1 year
Incidence of adverse events
Time frame: Any time
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 10 Jan 2019.
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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.
Richard C Lehman, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoFit™ Porous Tissue Matrix™ in people with Bone Graft and Knee, run by Zimmer Biomet at 1 site 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 1 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 10 Jan 2019. 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 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 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?
Site repair grade by MRI analysis (time frame: 6 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 Jan 2019.