Hallux Valgus
Conditions
Keywords
hallux valgus, chevron osteotomy, bioabsorbable screw, steel screw
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)
Interventions
DEVICEbioabsorbable screws
Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the bioabsorbable screw
DEVICEsteel screws
Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the steel screw
Sponsors
Second Hospital of Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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, 0means worst while 100 means best of the outcome. It was used as a standard evaluation method of hallux valgus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Outcome results
None listed