An interventional study of bioabsorbable screws and steel screws in Hallux Valgus, sponsored by Second Hospital of Jilin University. Status unknown. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-22.
Sponsored by Second Hospital of Jilin University · Not applicable, Interventional, and Treatment
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)
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 50 is below the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Second Hospital of Jilin University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
hallux valgus treated with chevron osteotomy using bioabsorbable screws
Device: bioabsorbable 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 bioabsorbable screw
Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the steel screw
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.
Time frame: pre-op,6 weeks,12 weeks and 1 year after operation
Radiographic outcomes parameters
IMA (intermetatarsal angle ),HVA (hallux valgus angle) measured in weight-bearing anteroposterior of foot
Time frame: 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
Time frame: pre-op,6 weeks,12 weeks and 1 year after operation
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Mar 2018; primary completion for Sep 2019, 18 months later.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 18 months is below that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Second Hospital of Jilin University