OsteoarthritisNCT00786942
Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy
A study testing high tibial osteotomy and higi tibial osteotomy in people with Osteoarthritis, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
The purpose of this study is to determine wether autologous bone graft from iliac crest enhances bone union of tibial osteotomies, in the treatment of varus knee deformity. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- high tibial osteotomy and higi tibial osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2006to Apr 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- varus knee deformity
- unicompartmental arthrosis
Who cannot join
- patellar arthrosis
- lateral arthrosis
- inflammatory diseases
- bone healing impair drugs or diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Departamento de Ortopedia do Hospital de Clínicas da Unicamp
Campinas, São Paulo, 13084-971
About this study
Official title: Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy. A Randomized Clinical Trial
The purpose of this study is to determine wether autologous bone graft from iliac crest enhances bone union of tibial osteotomies, in the treatment of varus knee deformity.
Read the detailed description
Opening-Wedge High Tibial Osteotomy is a classic procedure,but the use of autologous bone graft from iliac crest causes pain and bleeding. Bone union occur even without bone graft, but no clinical trials compared results of the twoo procedures.
- Conditions
- Osteoarthritis
- Being tested
- high tibial osteotomy, higi tibial osteotomy
- Keywords
- osteotomy, knee, varus deformity, bone graft
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tibial osteotomyProcedure or surgery
Also called opening-wedge higi tibial osteotomy
addition of bone graft to fill the osteotomy gap
higi tibial osteotomyProcedure or surgery
Also called opening-wedge higi tibial osteotomy
the gap of the tibia is unfilled
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | autologous bone graft Receives: Procedure: high tibial osteotomy |
| 2 | Experimental | without bone graft Receives: Procedure: higi tibial osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical based bone union time
Measured: after 8 weeks
Secondary outcomes (1)
X-ray femoro-tibial angle
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startApr 2006
- Primary completionApr 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Investigators
- Alessandro R Zorzi, MD, Principal investigator, University of Campinas, BrazilJoão B Miranda, MD, PhD, Study chair, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786942
- Sponsor's protocol ID
- Puddu
- Status last verified
- May 2010
- First submitted
- 5 Nov 2008
- Last updated
- 24 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00786942
- Acronym / sponsor ID
- Puddu
- Conditions
- Osteoarthritis
- Keywords
- osteotomy, knee, varus deformity, bone graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 Nov 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 purpose of this study is to determine wether autologous bone graft from iliac crest enhances bone union of tibial osteotomies, in the treatment of varus knee deformity.
Detailed description
Opening-Wedge High Tibial Osteotomy is a classic procedure,but the use of autologous bone graft from iliac crest causes pain and bleeding. Bone union occur even without bone graft, but no clinical trials compared results of the twoo procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: high tibial osteotomyautologous bone graft |
| 2 | Experimental | Procedure: higi tibial osteotomywithout bone graft |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- varus knee deformity
- unicompartmental arthrosis
Key exclusion criteria (4 listed)
- patellar arthrosis
- lateral arthrosis
- inflammatory diseases
- bone healing impair drugs or diseases
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 |
|---|---|---|
| high tibial osteotomyAlso: opening-wedge higi tibial osteotomyaddition of bone graft to fill the osteotomy gap | Procedure or surgery | 1 |
| higi tibial osteotomyAlso: opening-wedge higi tibial osteotomythe gap of the tibia is unfilled | Procedure or surgery | 2 |
Primary outcome
Clinical based bone union time
Time frame: after 8 weeks
1 secondary outcome
X-ray femoro-tibial angle
Time frame: 6 months, 1 year
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 24 May 2010.
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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.
Alessandro R Zorzi, MD principal investigator
University of Campinas, Brazil
João B Miranda, MD, PhD study chair
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high tibial osteotomy and higi tibial osteotomy in people with Osteoarthritis, run by University of Campinas, Brazil at 1 site in Brazil.
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 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 24 May 2010. 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 Brazil. 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?
Clinical based bone union time (time frame: after 8 weeks). 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 24 May 2010.