Coxa VaraCoxavaraNCT05842252
Single-stage Correction of Acute Angle Coxa Vara
A study testing greater trochanter transfer, subtrochanteric valgus osteotomy in people with Coxa Vara, run by Assiut University at 1 site in Egypt.
Trial summary
Correction of sever degree of coxa vara in single-stage correction. Read more about this study
- Who is it for?
- Ages 3 to 40 years
- Conditions the study is for
- Coxa Vara
- What is being tested?
- greater trochanter transfer, subtrochanteric valgus osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 15 May 2024
- 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 3 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- acute coxa vara
Who cannot join
- osteopenic oI
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine Assiut university
Asyut, 71515
Hesham M Elbaseet, MD, +2001007780689, drhesham20@aun.edu.eg
About this study
Correction of sever degree of coxa vara in single-stage correction.
Read the detailed description
The technique described in this article illustrates how to fully correct acute angle developmental coxa vara (neck shaft angle 30 degrees) to obtain better radiological and functional outcomes.
GT transfer Subtroch. valgus osteotomy
- Conditions
- Coxa Vara
- Being tested
- greater trochanter transfer, subtrochanteric valgus osteotomy
- Keywords
- coxa vara, proximal femur osteotomy, subtrochanteric valgus osteotomy, Wagner technique, tension band wiring., greater trochanter transfer
- Medical subject headings
- Coxa Vara
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
greater trochanter transfer, subtrochanteric valgus osteotomyProcedure or surgery
greater trochanter transfer, subtrochanteric valgus osteotomy fixation by wagner TB and locked plate
| Study group | Role | What they receive |
|---|---|---|
| greater trochanter transfer and subtrochanteric valgus osteotomy | Experimental | greater trochanter transfer, subtrochanteric valgus osteotomy fixation by Wagner \& TB and Locked plate Receives: Procedure: greater trochanter transfer, subtrochanteric valgus osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified McKay's criteria
Hip function score
- Excelent
- Good
- Fair
- Poor
Measured: 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 May 2023
- Study start15 May 2023
- Primary completion15 May 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coxa VaraStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- greater trochanter transfer and subtrochanteric valgus osteotomy
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohamed Elbaseet, Assiut University
- Investigators
- Hesaham M Elbaseet, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842252
- Sponsor's protocol ID
- ACUTECOXAVARA
- Acronym
- Coxavara
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srisaarn T, Salang K, Klawson B, Vipulakorn K, Chalayon O, Eamsobhana P. Surgical correction of coxa vara: Evaluation of neck shaft angle, Hilgenreiner-epiphyseal angle for indication of recurrence. J Clin Orthop Trauma. 2019 May-Jun;10(3):593-598. doi: 10.1016/j.jcot.2018.06.009. Epub 2018 Jun 28.
PubMed 31061596Galal S. Percutaneous multiplanar subtrochanteric osteotomy with external fixation for developmental coxa vara (preliminary results). J Pediatr Orthop B. 2017 Jul;26(4):320-328. doi: 10.1097/BPB.0000000000000392.
PubMed 27748677
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-stage Correction of Acute Angle Coxa Vara
- ClinicalTrials.gov ID
- NCT05842252
- Acronym / sponsor ID
- Coxavara / ACUTECOXAVARA
- Conditions
- Coxa Vara
- Keywords
- coxa vara, proximal femur osteotomy, subtrochanteric valgus osteotomy, Wagner technique, tension band wiring., greater trochanter transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- 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.
Correction of sever degree of coxa vara in single-stage correction.
Detailed description
The technique described in this article illustrates how to fully correct acute angle developmental coxa vara (neck shaft angle 30 degrees) to obtain better radiological and functional outcomes.
GT transfer Subtroch. valgus osteotomy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- greater trochanter transfer and subtrochanteric valgus osteotomy
| Arm | Type | Receives |
|---|---|---|
| greater trochanter transfer and subtrochanteric valgus osteotomy | Experimental | Procedure: greater trochanter transfer, subtrochanteric valgus osteotomygreater trochanter transfer, subtrochanteric valgus osteotomy fixation by Wagner \& TB and Locked plate |
Who may qualify
- Ages
- 3 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- acute coxa vara
Key exclusion criteria (1 listed)
- osteopenic oI
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 |
|---|---|---|
| greater trochanter transfer, subtrochanteric valgus osteotomygreater trochanter transfer, subtrochanteric valgus osteotomy fixation by wagner TB and locked plate | Procedure or surgery | greater trochanter transfer and subtrochanteric valgus osteotomy |
Primary outcome
modified McKay's criteria
Time frame: 1 year
Hip function score 1. Excelent 2. Good 3. Fair 4. Poor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Background: PubMed 31061596Srisaarn T, Salang K, Klawson B, Vipulakorn K, Chalayon O, Eamsobhana P. Surgical correction of coxa vara: Evaluation of neck shaft angle, Hilgenreiner-epiphyseal angle for indication of recurrence. J Clin Orthop Trauma. 2019 May-Jun;10(3):593-598. doi: 10.1016/j.jcot.2018.06.009. Epub 2018 Jun 28.
- Background: PubMed 27748677Galal S. Percutaneous multiplanar subtrochanteric osteotomy with external fixation for developmental coxa vara (preliminary results). J Pediatr Orthop B. 2017 Jul;26(4):320-328. doi: 10.1097/BPB.0000000000000392.
- Individual participant dataSharing planned: No
Related trials for Coxa Vara
RecruitingObservational study
CACP: Study on Camptodactyly - Arthropathy - Coxa Vara - Pericarditis (CACP) Syndrome
Camptodactyly, Arthropathy
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.
Hesaham M Elbaseet, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing greater trochanter transfer, subtrochanteric valgus osteotomy in people with Coxa Vara, run by Assiut University at 1 site in Egypt.
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 1 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 23 May 2023. 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 Egypt. 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?
Contact Hesaham M Elbaseet, MD (+2001007780689, drhesham20@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified McKay's criteria (time frame: 1 year). 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 NCT05842252, which also lists 2 linked publications.
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 23 May 2023.