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

Primary Purpose

Hallux Valgus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bioabsorbable screws
steel screws
Sponsored by
Second Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring hallux valgus, chevron osteotomy, bioabsorbable screw, steel screw

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    bioabsorbable screws

    steel screws

    Arm Description

    hallux valgus treated with chevron osteotomy using bioabsorbable screws

    hallux valgus treated with chevron osteotomy using steel screws

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Radiographic outcomes parameters
    IMA (intermetatarsal angle ),HVA (hallux valgus angle) measured in weight-bearing anteroposterior of foot
    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

    Full Information

    First Posted
    March 10, 2018
    Last Updated
    March 20, 2018
    Sponsor
    Second Hospital of Jilin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03470623
    Brief Title
    Comparison of Bioabsorbable and Steel Screw for the Treatment of Hallux Valgus With Chevron Osteotomy
    Official Title
    Randomized, Prospective Comparison of Bioabsorbable and Steel Screw for the Treatment of Hallux Valgus With Chevron Osteotomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    February 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Hospital of Jilin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hallux Valgus
    Keywords
    hallux valgus, chevron osteotomy, bioabsorbable screw, steel screw

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    bioabsorbable screws
    Arm Type
    Experimental
    Arm Description
    hallux valgus treated with chevron osteotomy using bioabsorbable screws
    Arm Title
    steel screws
    Arm Type
    Experimental
    Arm Description
    hallux valgus treated with chevron osteotomy using steel screws
    Intervention Type
    Device
    Intervention Name(s)
    bioabsorbable screws
    Intervention Description
    Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the bioabsorbable screw
    Intervention Type
    Device
    Intervention Name(s)
    steel screws
    Intervention Description
    Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the steel screw
    Primary Outcome Measure Information:
    Title
    American orthopedic foot and ankle society forefoot score change
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Radiographic outcomes parameters
    Description
    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
    Title
    VAS score
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: hallux valgus treated with distal chevron osteotomy age between 18-70 Exclusion Criteria: hallux valgus treated with other procedure (scarf,ludloff,lapidus,etc) age <18 or age >70 rheumatoid osteoporosis -

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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