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

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ClinicalTrials.gov Identifier: NCT03470623
Recruitment Status : Not yet recruiting
First Posted : March 20, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Second Hospital of Jilin University

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)


Condition or disease Intervention/treatment Phase
Hallux Valgus Device: bioabsorbable screws Device: steel screws Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Prospective Comparison of Bioabsorbable and Steel Screw for the Treatment of Hallux Valgus With Chevron Osteotomy
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




Primary Outcome Measures :
  1. American orthopedic foot and ankle society forefoot score change [ Time Frame: 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, "0"means worst while "100" means best of the outcome. It was used as a standard evaluation method of hallux valgus.


Secondary Outcome Measures :
  1. Radiographic outcomes parameters [ Time Frame: 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

  2. VAS score [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 -

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Responsible Party: Second Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT03470623    
Other Study ID Numbers: 00123456
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Hospital of Jilin University:
hallux valgus
chevron osteotomy
bioabsorbable screw
steel screw
Additional relevant MeSH terms:
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Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired