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

Not Applicable

• Conditions: Hallux Valgus
• Interventions: Device: steel screws; Device: bioabsorbable screws

• Registration Number: NCT03470623
• Lead Sponsor: Second Hospital of Jilin University

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-03
• Study Start: 2018-03
• Study First Submitted: 2018-03-10
• Study First Submitted QC: 2018-03-18
• Study First Posted: 2018-03-20
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22
• Primary Completion: 2019-09
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. hallux valgus treated with distal chevron osteotomy
2. age between 18-70

Exclusion Criteria

1. hallux valgus treated with other procedure (scarf,ludloff,lapidus,etc)
2. age <18 or age >70
3. rheumatoid
4. osteoporosis -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
steel screws	steel screws	hallux valgus treated with chevron osteotomy using steel screws
bioabsorbable screws	bioabsorbable screws	hallux valgus treated with chevron osteotomy using bioabsorbable screws

Primary Outcome Measures

Name	Time	Method
American orthopedic foot and ankle society forefoot score change	pre-op,6 weeks,12 weeks and 1 year after operation	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, "0"means worst while "100" means best of the outcome. It was used as a standard evaluation method of hallux valgus.

Secondary Outcome Measures

Name	Time	Method
VAS score	pre-op,6 weeks,12 weeks and 1 year after operation	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
Radiographic outcomes parameters	pre-op,6 weeks,12 weeks and 1 year after operation	IMA (intermetatarsal angle ),HVA (hallux valgus angle) measured in weight-bearing anteroposterior of foot