Clinical trial NCT06584487: Proximal Metatarsal Osteotomy in Correction of Hallux Valgus
Official title: Proximal Metatarsal Medial Opening Wedge Osteotomy Fixed by Plate and Screws in Correction of Hallux Valgus
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hallux Valgus and Bunion
Keywords: Proximal Osteotomy
Medial Opening Wedge
Hallux Valgus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 15
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient above 15 years old

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* all admitted patients to Assiut University Hospitals.
* age group of 15 years old and above.
* Moderate and severe degrees of hallux valgus.

Exclusion Criteria:

* Burn
* age group below 15 years old.
* patient who refuse to participate in the study.

Primary outcomes:
measure: The American Orthopedic Foot and Ankle Society hallux-metatarsophalangeal-interphalangeal scale (AOFAS scale).
timeFrame: baseline
Secondary outcomes:
measure: Post operative radiographic changes in standing AP view foot and standing lateral view foot.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Abdulrahman M Hussein Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Saragas 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.
citation: Robinson 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.
citation: Okuda 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.
citation: Thordarson 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.