GenovarumPhase 3NCT00595712
Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft
A Phase 3 study testing Iliac crest allograft and Iliac crest autograft in people with Genovarum, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in patients with genovarum deformity using iliac crest allograft compared to the results when using iliac crest autograft. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Genovarum
- What is being tested?
- Iliac crest allograft and Iliac crest autograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Sep 2007to Feb 2010
- Phase
- Phase 3
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Varus malalignment of knee with of without osteoarthritis: the angle between the articular surface and anatomical axis of tibia< 82 degrees
- at least 7.5 mm opening wedge is needed in medial proximal tibia to correct the deformity assessed during pre-op planning
Who cannot join
- symptomatic lateral compartment osteoarthritis of knee
- rheumatoid arthritis or other inflammatory joint diseases
- less than 100 degrees of knee range of motion
- grade III laxity in knee collateral ligaments
- history of surgery or fracture in the limb
- >15 degrees flexion contracture
Show all 15Show fewer
- age <16 or >60 years
- >20 degrees varus deformity
- failure to attend follow-up visits
- sever bone loss in medial tibial plateau or medial femoral condyle
- >1cm joint subluxation
- presence of lateral trust during walking
- presence of patella baja
- skin derangements on medial proximal tibia
- any form of nicotine addiction
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in patients with genovarum deformity using iliac crest allograft compared to the results when using iliac crest autograft.
- Conditions
- Genovarum
- Being tested
- Iliac crest allograft, Iliac crest autograft
- Keywords
- Genovarum, Medial opening-wedge high tibial osteotomy, allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iliac crest allograftProcedure or surgery
Opening wedge osteotomy of proximal tibia with allograft from iliac crest
Iliac crest autograftProcedure or surgery
open wedge osteotomy of proximal tibia using autogenous iliac bone graft
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Using Iliac crest allograft in high tibial osteotomy Receives: Procedure: Iliac crest allograft |
| B | Active comparator | Using iliac crest autograft in high tibial osteotomy Receives: Procedure: Iliac crest autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion of the knee
Measured: before op and at follow ups
knee score (womac)
Measured: before op and at final follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GenovarumStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Seyyed Mohammad J Mortazavi, M.D., Study director, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595712
- Sponsor's protocol ID
- 86-09-30-4111
- Status last verified
- May 2010
- First submitted
- 5 Jan 2008
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Haghpanah B, Kaseb MH, Espandar R, Mortazavi SMJ. No difference in union and recurrence rate between iliac crest autograft versus allograft following medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3375-3381. doi: 10.1007/s00167-020-06240-w. Epub 2020 Aug 24.
PubMed 32839849
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft
- ClinicalTrials.gov ID
- NCT00595712
- Acronym / sponsor ID
- 86-09-30-4111
- Conditions
- Genovarum
- Keywords
- Genovarum, Medial opening-wedge high tibial osteotomy, allograft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Jan 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 RCT is to determine the results of opening-wedge high tibial osteotomy in patients with genovarum deformity using iliac crest allograft compared to the results when using iliac crest autograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Iliac crest allograftUsing Iliac crest allograft in high tibial osteotomy |
| B | Active comparator | Procedure: Iliac crest autograftUsing iliac crest autograft in high tibial osteotomy |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Varus malalignment of knee with of without osteoarthritis: the angle between the articular surface and anatomical axis of tibia< 82 degrees
- at least 7.5 mm opening wedge is needed in medial proximal tibia to correct the deformity assessed during pre-op planning
Key exclusion criteria (15 listed)
- symptomatic lateral compartment osteoarthritis of knee
- rheumatoid arthritis or other inflammatory joint diseases
- less than 100 degrees of knee range of motion
- grade III laxity in knee collateral ligaments
- history of surgery or fracture in the limb
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 |
|---|---|---|
| Iliac crest allograftOpening wedge osteotomy of proximal tibia with allograft from iliac crest | Procedure or surgery | A |
| Iliac crest autograftopen wedge osteotomy of proximal tibia using autogenous iliac bone graft | Procedure or surgery | B |
Primary outcome
Range of motion of the knee
Time frame: before op and at follow ups
knee score (womac)
Time frame: before op and at final follow up
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 25 May 2010.
- Derived from this study: PubMed 32839849Haghpanah B, Kaseb MH, Espandar R, Mortazavi SMJ. No difference in union and recurrence rate between iliac crest autograft versus allograft following medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3375-3381. doi: 10.1007/s00167-020-06240-w. Epub 2020 Aug 24.
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.
Seyyed Mohammad J Mortazavi, M.D. study director
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iliac crest allograft and Iliac crest autograft in people with Genovarum, run by Tehran University of Medical Sciences at 1 site in Iran.
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 15 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 25 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 Iran. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Range of motion of the knee (time frame: before op and at follow ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00595712, which also lists 1 linked publication.
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 25 May 2010.