Efficacy of Additional Osteotomies to Correct Hallux Valgus

Study Overview
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Brief Summary
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Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). Angle between M1 and the second metatarsal (M2) is named InterMetatarsal Angle (IMA). Angle between M1 distal articular surface and M1 shaft axis in a frontal plane is named Distal Metatarsal Articular Angle (DMAA). Insufficient surgical correction is a risk factor of recurrence (HVA>20° after surgery). According to Okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : HVA>40° before the surgery and HVA>15° with an IMA>10° 10 weeks (3-24) after the surgery. Currently, one of the most common used procedure is a translated (laterally) distal chevron associated with a release of the metatarso-sesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct deformation in all plans. HVA and IMA are corrected but DMAA and M1 pronation angle are not. Surgeons can add three different osteotomies in this type of chevron. In the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. No studies have tried to assess these three possibilities. The investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up

Official Title
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Is it Better to Add Supination Osteotomy, Varisation Osteotomy, or Both to Distal Chevron as Part of Hallux Valgus Management : a Prospective Randomized Trial

Conditions
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Hallux Valgus

Intervention / Treatment
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* Procedure: additional osteotomies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient older than 18 years. Informed consent Exclusion Criteria: Associated lesser metatarsals surgery. Associated surgery on midfoot, hindfoot or ankle. Neurologic diseases (Charcot Marie Tooth disease, poliomyelitis, compartment syndrome sequelae) Clinical or X-ray degenerative signs (Hallux rigidus) or irreducible deformations (MTP1 arthrodesis indications). Patient who declined the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No additional osteotomy<br> | Procedure: additional osteotomies<br>* varisation osteotomy, supination osteotomy or both<br>|
| Experimental: varisation osteotomy addition<br> | Procedure: additional osteotomies<br>* varisation osteotomy, supination osteotomy or both<br>|
| Experimental: supination osteotomy addition<br> | Procedure: additional osteotomies<br>* varisation osteotomy, supination osteotomy or both<br>|
| Experimental: both (varisation + supination) osteotomies addition.<br> | Procedure: additional osteotomies<br>* varisation osteotomy, supination osteotomy or both<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10° | on weight bearing X-Rays | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of hallux valgus (HVA>20°). |  | 5 years | 
| American Orthopedic Foot and Ankle Forefoot Score (AOFAS) | Mini 0 (Worse) - Maxi 100 (Better) | 6 months | 
| American Orthopedic Foot and Ankle Forefoot Score (AOFAS) | Mini 0 (Worse) - Maxi 100 (Better) | 5 years | 
| Patient satisfaction (Likert scale) | very satisfied/satisfied/fairly satisfied/no satisfied | 6 months | 
| Patient satisfaction (Likert scale) | very satisfied/satisfied/fairly satisfied/no satisfied | 5 years |