Comparison of Bioabsorbable and Steel Screw for the Treatment of Hallux Valgus With Chevron Osteotomy

Study Overview
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Brief Summary
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Hallux valgus is the most common deformity of forefoot and the patients would suffer pain and disable of walking and wearing normal shoes. Chevron osteotomy of the first metatarsal is widely used for the treatment of mild or medium hallux valgus. It is a V sharp osteotomy that can decrease the intermetatarsal degree of first-second metatarsal by pushing the distal side of osteotomy laterally.A 2.5mm or 3.0mm steel cannulated screw is usually used for the fixation of the osteotomy side to provide stability.However,there are some shortcomings of steel screws such as rejection of internal fixation or the financial cost of the second surgery of fixation taken-out. To obviate these shortcomings of steel screws, bioabsorbable screw fixation may be an alternative method for chevron osteotomy. This trial is a randomized, prospective, controlled, parallel experimental design, to compare the clinical and radiographic outcomes of bioabsorbable screw versus steel screw for the treatment of hallux valgus with chevron osteotomy. The patients will be randomized to two groups, one treated with bioabsorbable screws while the other treated with steel screws.Data collection for the outcomes measures will occur pre-op,immediate post-op and then 6 weeks, 12 weeks, and at 1 years post operation. The clinical outcomes measure are the VAS (visual analogue scale) score and AOFAS (American orthopedic foot and ankle society) forefoot score.The radiographic outcomes measures are the IMA (intermetatarsal angle) and the HVA (hallux valgus angle)

Official Title
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Randomized, Prospective Comparison of Bioabsorbable and Steel Screw for the Treatment of Hallux Valgus With Chevron Osteotomy

Conditions
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Hallux Valgus

Intervention / Treatment
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* Device: bioabsorbable screws
* Device: steel screws


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hallux valgus treated with distal chevron osteotomy age between 18-70 Exclusion Criteria: hallux valgus treated with other procedure (scarf,ludloff,lapidus,etc) age <18 or age >70 rheumatoid osteoporosis -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bioabsorbable screws<br>hallux valgus treated with chevron osteotomy using bioabsorbable screws | Device: bioabsorbable screws<br>* Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the bioabsorbable screw<br>|
| Experimental: steel screws<br>hallux valgus treated with chevron osteotomy using steel screws | Device: steel screws<br>* Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the steel screw<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American orthopedic foot and ankle society forefoot score change | American orthopedic foot and ankle society forefoot score was consist of pain,ability of walking and alignment.The minimum score is 0 and the maximum score is 100, 0means worst while 100 means best of the outcome. It was used as a standard evaluation method of hallux valgus. | pre-op,6 weeks,12 weeks and 1 year after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic outcomes parameters | IMA (intermetatarsal angle ),HVA (hallux valgus angle) measured in weight-bearing anteroposterior of foot | pre-op,6 weeks,12 weeks and 1 year after operation | 
| VAS score | Visual Analogue Scale,a widely used score about pain. It present different level of pain by using the number 0-10. 0 present no pain while 10 present worst pain | pre-op,6 weeks,12 weeks and 1 year after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hallux valgus, chevron osteotomy, bioabsorbable screw, steel screw