Osteoarthritis of the KneeNCT00200603
Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy
A study testing calcium phosphate macroporous bioceramics in people with Osteoarthritis of the Knee, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of the study is to compare radiological behavior of blocks of macroporous phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus osteotomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- calcium phosphate macroporous bioceramics
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- May 1999to not given
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee osteoarthritis eligible for tibial valgus osteotomy
- > 18 y.o
Who cannot join
- prior tibial osteotomy
- history of local infection
- rheumatoid and other inflammatory arthritis
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare radiological behavior of blocks of macroporous phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus osteotomy.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- calcium phosphate macroporous bioceramics
- Keywords
- Calcium phosphate ceramic, tibial osteotomy, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium phosphate macroporous bioceramicsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological healing and stability of the osteotomy measure at 3, 6, 12 and 24 months after surgery
Secondary outcomes (1)
Knee and iliac crest painSurgical complicationsFonctional results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- François Gouin, MD, Principal investigator, Nantes UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200603
- Sponsor's protocol ID
- BRD/99/3-G
- Status last verified
- May 2004
- First submitted
- 9 Sep 2005
- Last updated
- 16 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy
- ClinicalTrials.gov ID
- NCT00200603
- Acronym / sponsor ID
- BRD/99/3-G
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Calcium phosphate ceramic, tibial osteotomy, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- May 1999
- First posted
- 20 Sep 2005 (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 aim of the study is to compare radiological behavior of blocks of macroporous phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus osteotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- knee osteoarthritis eligible for tibial valgus osteotomy
- > 18 y.o
Key exclusion criteria (3 listed)
- prior tibial osteotomy
- history of local infection
- rheumatoid and other inflammatory arthritis
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 |
|---|---|---|
| calcium phosphate macroporous bioceramics | Device | – |
Primary outcome
Radiological healing and stability of the osteotomy measure at 3, 6, 12 and 24 months after surgery
1 secondary outcome
Knee and iliac crest painSurgical complicationsFonctional results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2005.
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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.
François Gouin, MD principal investigator
Nantes UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcium phosphate macroporous bioceramics in people with Osteoarthritis of the Knee, run by Nantes University Hospital at 1 site in France.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Dec 2005. 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 France. 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?
Results are not available in the source record.
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?
Radiological healing and stability of the osteotomy measure at 3, 6, 12 and 24 months after surgery. 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 16 Dec 2005.