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
1 other identifier
interventional
50
0 countries
N/A
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 10, 2018
CompletedFirst Posted
Study publicly available on registry
March 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedMarch 22, 2018
March 1, 2018
1.5 years
March 10, 2018
March 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Radiographic outcomes parameters
pre-op,6 weeks,12 weeks and 1 year after operation
VAS score
pre-op,6 weeks,12 weeks and 1 year after operation
Study Arms (2)
bioabsorbable screws
EXPERIMENTALhallux valgus treated with chevron osteotomy using bioabsorbable screws
steel screws
EXPERIMENTALhallux valgus treated with chevron osteotomy using steel screws
Interventions
Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the bioabsorbable screw
Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the steel screw
Eligibility Criteria
You may qualify if:
- hallux valgus treated with distal chevron osteotomy
- age between 18-70
You may not qualify if:
- hallux valgus treated with other procedure (scarf,ludloff,lapidus,etc)
- age \<18 or age \>70
- rheumatoid
- osteoporosis -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2018
First Posted
March 20, 2018
Study Start
March 1, 2018
Primary Completion
September 1, 2019
Study Completion
February 1, 2020
Last Updated
March 22, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share