Hallux Valgus and BunionNCT06584487
Proximal Metatarsal Osteotomy in Correction of Hallux Valgus
An observational study of Hallux Valgus and Bunion, run by Assiut University.
Trial summary
The outcomes of the correction of hallux valgus by proximal opening wedge osteotomy Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus and Bunion
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to Oct 2025
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patient above 15 years old
Who may be able to join
- all admitted patients to Assiut University Hospitals.
- age group of 15 years old and above.
- Moderate and severe degrees of hallux valgus.
Who cannot join
- Burn
- age group below 15 years old.
- patient who refuse to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Proximal Metatarsal Medial Opening Wedge Osteotomy Fixed by Plate and Screws in Correction of Hallux Valgus
The outcomes of the correction of hallux valgus by proximal opening wedge osteotomy
Read the detailed description
Hallux valgus is a common cause of foot pain and deformity in the adult and adolescent population, which often requires surgical treatment when nonsurgical treatments fail.
During the past decades, multiple modified procedures and fixation techniques have been described.
The most common types of osteotomies of the first metatarsal are crescentic, chevron, scarf and lateral or medial opening wedge techniques.
A concern with the Chevron and other distal osteotomies is the development of avascular necrosis of the first metatarsal head with a reported incidence of between 0% and 20%.
On the other side, the proximal dome osteotomy along with a distal soft tissue release is an excellent procedure. The proximal location of the osteotomy avoids devascularization of the metatarsal head, and the crescent shape maintains the length of the metatarsal. It allows a high degree of correction at the intermetatarsal angle in severe deformities.
When the condition is associated with an increased intermetatarsal angle, a surgical technique using a proximal first metatarsal osteotomy is often indicated. A proximal opening wedge osteotomy stabilized with a wedge and plate configuration offers a stable, reliable means to correct the increased intermetatarsal angle.
Over the past 10 years, some surgeons have increasingly used locking plates instead of a single screw for stabilisation of the osteotomy with the assumption of better postoperative stability and preserved length of the first metatarsal. In addition, fixation with a plate has been described as technically less challenging.
- Conditions
- Hallux Valgus and Bunion
- Keywords
- Proximal Osteotomy, Medial Opening Wedge, Hallux Valgus
- Medical subject headings
- Hallux Valgus, Bunion
What is being measured
The primary outcome is the main question the study is designed to answer.
The American Orthopedic Foot and Ankle Society hallux-metatarsophalangeal-interphalangeal scale (AOFAS scale).
Pain-Function-Alignment
Measured: baseline
Secondary outcomes (1)
Post operative radiographic changes in standing AP view foot and standing lateral view foot.
In standing AP view foot
- The hallux valgus angle HVA in degrees.It is the angle between long axis of 1st metatarsal and proximal phalanx of big toe
- The intermetatarsal angle IMA in degree
- The distal metatarsal articular angle DMAA in degree
- The 1st metatarsal length in centimeter In standing lateral view foot
- The inclination angle of the 1st metatarsal in degree In standing AP view foot
- The hallux valgus angle HVA in degree
- The intermetatarsal angle IMA in degree
- The distal metatarsal articular angle DMAA in degree
- The 1st metatarsal length in centimeter In standing lateral view foot
- The inclination angle of the 1st metatarsal
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start10 Oct 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hallux Valgus and BunionStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Mahdi Hussein Mohamed, Assiut University
- Investigators
- Abdulrahman M Hussein Mohamed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584487
- Sponsor's protocol ID
- Hallux valgus osteotomy
- Status last verified
- Sep 2024
- First submitted
- 14 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Markbreiter LA, Thompson FM. Proximal metatarsal osteotomy in hallux valgus correction: a comparison of crescentic and chevron procedures. Foot Ankle Int. 1997 Feb;18(2):71-6. doi: 10.1177/107110079701800205.
PubMed 9043877Saragas NP. Proximal opening-wedge osteotomy of the first metatarsal for hallux valgus using a low profile plate. Foot Ankle Int. 2009 Oct;30(10):976-80. doi: 10.3113/FAI.2009.0976.
PubMed 19796591Robinson AH, Limbers JP. Modern concepts in the treatment of hallux valgus. J Bone Joint Surg Br. 2005 Aug;87(8):1038-45. doi: 10.1302/0301-620X.87B8.16467. No abstract available.
PubMed 16049235Okuda R, Kinoshita M, Yasuda T, Jotoku T, Shima H. Proximal metatarsal osteotomy for hallux valgus: comparison of outcome for moderate and severe deformities. Foot Ankle Int. 2008 Jul;29(7):664-70. doi: 10.3113/FAI.2008.0664.
PubMed 18785415Thordarson DB, Leventen EO. Hallux valgus correction with proximal metatarsal osteotomy: two-year follow-up. Foot Ankle. 1992 Jul-Aug;13(6):321-6. doi: 10.1177/107110079201300605.
PubMed 1398360
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Metatarsal Medial Opening Wedge Osteotomy Fixed by Plate and Screws in Correction of Hallux Valgus
- ClinicalTrials.gov ID
- NCT06584487
- Acronym / sponsor ID
- Hallux valgus osteotomy
- Conditions
- Hallux Valgus and Bunion
- Keywords
- Proximal Osteotomy, Medial Opening Wedge, Hallux Valgus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 4 Sep 2024 (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.
The outcomes of the correction of hallux valgus by proximal opening wedge osteotomy
Detailed description
Hallux valgus is a common cause of foot pain and deformity in the adult and adolescent population, which often requires surgical treatment when nonsurgical treatments fail.
During the past decades, multiple modified procedures and fixation techniques have been described.
The most common types of osteotomies of the first metatarsal are crescentic, chevron, scarf and lateral or medial opening wedge techniques.
A concern with the Chevron and other distal osteotomies is the development of avascular necrosis of the first metatarsal head with a reported incidence of between 0% and 20%.
On the other side, the proximal dome osteotomy along with a distal soft tissue release is an excellent procedure. The proximal location of the osteotomy avoids devascularization of the metatarsal head, and the crescent shape maintains the length of the metatarsal. It allows a high degree of correction at the intermetatarsal angle in severe deformities.
When the condition is associated with an increased intermetatarsal angle, a surgical technique using a proximal first metatarsal osteotomy is often indicated. A proximal opening wedge osteotomy stabilized with a wedge and plate configuration offers a stable, reliable means to correct the increased intermetatarsal angle.
Over the past 10 years, some surgeons have increasingly used locking plates instead of a single screw for stabilisation of the osteotomy with the assumption of better postoperative stability and preserved length of the first metatarsal. In addition, fixation with a plate has been described as technically less challenging.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patient above 15 years old
Key inclusion criteria (3 listed)
- all admitted patients to Assiut University Hospitals.
- age group of 15 years old and above.
- Moderate and severe degrees of hallux valgus.
Key exclusion criteria (3 listed)
- Burn
- age group below 15 years old.
- patient who refuse to participate in the study.
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
The American Orthopedic Foot and Ankle Society hallux-metatarsophalangeal-interphalangeal scale (AOFAS scale).
Time frame: baseline
Pain-Function-Alignment
1 secondary outcome
Post operative radiographic changes in standing AP view foot and standing lateral view foot.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 9043877Markbreiter LA, Thompson FM. Proximal metatarsal osteotomy in hallux valgus correction: a comparison of crescentic and chevron procedures. Foot Ankle Int. 1997 Feb;18(2):71-6. doi: 10.1177/107110079701800205.
- Background: PubMed 19796591Saragas NP. Proximal opening-wedge osteotomy of the first metatarsal for hallux valgus using a low profile plate. Foot Ankle Int. 2009 Oct;30(10):976-80. doi: 10.3113/FAI.2009.0976.
- Background: PubMed 16049235Robinson AH, Limbers JP. Modern concepts in the treatment of hallux valgus. J Bone Joint Surg Br. 2005 Aug;87(8):1038-45. doi: 10.1302/0301-620X.87B8.16467. No abstract available.
- Background: PubMed 18785415Okuda R, Kinoshita M, Yasuda T, Jotoku T, Shima H. Proximal metatarsal osteotomy for hallux valgus: comparison of outcome for moderate and severe deformities. Foot Ankle Int. 2008 Jul;29(7):664-70. doi: 10.3113/FAI.2008.0664.
- Background: PubMed 1398360Thordarson DB, Leventen EO. Hallux valgus correction with proximal metatarsal osteotomy: two-year follow-up. Foot Ankle. 1992 Jul-Aug;13(6):321-6. doi: 10.1177/107110079201300605.
- Individual participant dataSharing planned: Undecided
Related trials for Hallux Valgus and Bunion
Active, not recruiting
LSTR in Chevron Osteotomy
Bunion
Not yet recruiting
Prospective Study of Minimally Invasive Lapidus Procedure for Hallux Valgus Deformities
Hallux Valgus and Bunion
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.
Abdulrahman M Hussein Mohamed principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus and Bunion, run by Assiut University.
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 3 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 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Abdulrahman M Hussein Mohamed, Master (+2001063555610, Abd-Elrahman.20134151@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The American Orthopedic Foot and Ankle Society hallux-metatarsophalangeal-interphalangeal scale (AOFAS scale). (time frame: baseline). 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 NCT06584487, which also lists 5 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 4 Sep 2024.