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

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03470623
• Other study ID #: 00123456
• Status: Not yet recruiting
• Phase: N/A
• First received: March 10, 2018
• Last updated: March 20, 2018
• Start date: March 2018
• Est. completion date: February 2020

Study information

• Verified date: March 2018
• Source: Second Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus

Intervention

Device:
• bioabsorbable screws
Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the bioabsorbable screw
• steel screws
Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the steel screw

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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