Spinal FusionsNCT00768924
CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest
An observational study of Spinal Fusions, run by Zimmer Biomet at 1 site in United States.
Trial summary
The CopiOs Bone Void Filler (BVF) is a synthetic bone graft material consisting of calcium phosphate dehydrate within lyophilized type I bovine collagen that has been formed into pads of various sizes for surgical implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusions
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2008
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CopiOs will be used to fill the bony deficit as a result of iliac crest autograft harvest during spinal fusion surgery.
Who may be able to join
- Patient is 18 years and older
- Patient must be an appropriate candidate for iliac crest bone harvesting during a spinal fusion.
- Patient must be skeletally mature.
- Patient has signed an IRB approved Informed Consent and HIPAA compliant waiver.
Who cannot join
- Patient is suffering from any co-morbidities that would excessively increase the risk of surgery, including but not limited to pulmonary or cardiac conditions.
- Patient is pregnant.
- Patient has a severe degenerative bone disease.
- Patient has systemic conditions which would affect bone or wound healing.
- Patient is unwilling or unable to follow postoperative instructions or cooperate in a follow-up program.
- Patient is suffering from mental illness, alcohol abuse or drug abuse.
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- Patient has known allergies to bovine collagen.
- Patient has a history of multiple allergies.
- Patient has infection at the surgical site.
- Significantly impaired vascularity proximal to surgical site.
- Sites are in direct contact with articular space.
- Sites where stresses on void will exceed the load strength of fixation hardware.
- Patient has hypercalcemia.
Trial locations and contacts
1 site in 1 country.
About this study
The CopiOs Bone Void Filler (BVF) is a synthetic bone graft material consisting of calcium phosphate dehydrate within lyophilized type I bovine collagen that has been formed into pads of various sizes for surgical implantation. Pre-clinical animal studies suggest that the bone healing strength of CopiOs to be equivalent to autograft.
Read the detailed description
Purpose of the study is to evaluate the in-vivo use of CopiOs bone void filler in a single site trial, providing pre and post-operative evaluations of subjects undergoing spinal fusion with autogenous bone graft, in whom the CopiOs has been used as a bone void filler in the post-harvest iliac crest.
- Conditions
- Spinal Fusions
- Keywords
- Bone Void Filler, Post-Harvest Iliac Crest, Ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Spinal fusion patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data obtained by this study will provide valuable insight on the ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768924
- Sponsor's protocol ID
- 2006-012
- Status last verified
- Feb 2009
- First submitted
- 3 Oct 2008
- Last updated
- 30 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CopiOs(TM) Bone Void Filler in the Post-Harvest Iliac Crest
- ClinicalTrials.gov ID
- NCT00768924
- Acronym / sponsor ID
- 2006-012
- Conditions
- Spinal Fusions
- Keywords
- Bone Void Filler, Post-Harvest Iliac Crest, Ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Oct 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.
The CopiOs Bone Void Filler (BVF) is a synthetic bone graft material consisting of calcium phosphate dehydrate within lyophilized type I bovine collagen that has been formed into pads of various sizes for surgical implantation. Pre-clinical animal studies suggest that the bone healing strength of CopiOs to be equivalent to autograft.
Detailed description
Purpose of the study is to evaluate the in-vivo use of CopiOs bone void filler in a single site trial, providing pre and post-operative evaluations of subjects undergoing spinal fusion with autogenous bone graft, in whom the CopiOs has been used as a bone void filler in the post-harvest iliac crest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Spinal fusion patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CopiOs will be used to fill the bony deficit as a result of iliac crest autograft harvest during spinal fusion surgery.
Key inclusion criteria (4 listed)
- Patient is 18 years and older
- Patient must be an appropriate candidate for iliac crest bone harvesting during a spinal fusion.
- Patient must be skeletally mature.
- Patient has signed an IRB approved Informed Consent and HIPAA compliant waiver.
Key exclusion criteria (13 listed)
- Patient is suffering from any co-morbidities that would excessively increase the risk of surgery, including but not limited to pulmonary or cardiac conditions.
- Patient is pregnant.
- Patient has a severe degenerative bone disease.
- Patient has systemic conditions which would affect bone or wound healing.
- Patient is unwilling or unable to follow postoperative instructions or cooperate in a follow-up program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data obtained by this study will provide valuable insight on the ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion.
Time frame: 6 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 30 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusions, 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 4 inclusion and 13 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 30 Sep 2011. 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 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?
Data obtained by this study will provide valuable insight on the ability of CopiOs to fill the post-harvest iliac crest bone void created by a surgeon during spinal fusion. (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 30 Sep 2011.