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

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

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)

Study Overview

• Status: Unknown
• Conditions: Hallux Valgus
• Intervention / Treatment: Device: bioabsorbable screws; Device: steel screws

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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, "0"means 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

Collaborators and Investigators

• Sponsor: Second Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: March 10, 2018
• First Submitted That Met QC Criteria: March 18, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: hallux valgus; chevron osteotomy; bioabsorbable screw; steel screw
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion
• Other Study ID Numbers: 00123456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No