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Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance

Primary Purpose

Hand, Wrist, Wounds and Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous screw fixation through K-wire-assisted reduction and maintenance
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand

Eligibility Criteria

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

Inclusion Criteria:

  • acute scaphoid fractures
  • Injury to surgery less than 7 days
  • Only one injured hand
  • Written informed consent to undergo the surgical procedure
  • Patients of either sex aged between 18 and 70 years

Exclusion Criteria:

  • Patients with vascular injuried requiring revascularization
  • Concomitant phalanx fractures or other injuries needing immobilization
  • Loss of skin substance requiring grafts or flaps
  • Uncompensated diabetes, neoplasia, haemocoagulative alterations, psychic disorders
  • Smokers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    open reduction group

    percutaneous group

    Arm Description

    Outcomes

    Primary Outcome Measures

    The modified Mayo wrist scoring system
    The function outcomes including pain, work status, range of motion (Rom) and grip strength were assessed and graded as excellent, good , fair and poor.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 19, 2020
    Last Updated
    August 12, 2020
    Sponsor
    Hebei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04482868
    Brief Title
    Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance
    Official Title
    Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    September 6, 2018 (Actual)
    Study Completion Date
    December 29, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hebei Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The scaphoid is the most common fractured carpal bone in active adults, accounting for up to 80% of all carpal fractures. The optimum treatment approach of the acute scaphoid fractures is under discussion. Cast immobilization is the main treatment for non-displaced scaphoid fractures, however, about 20% of scaphoid fractures fail to heal with conservative treatment. Long periods of cast immobilization may result in wrist stiffness, loss of grip strength, muscle atrophy and disuse osteopenia. Operative treatment for displaced and unstable scaphoid fractures was mostly adopted, however, open fixation for scaphoid fractures have the inherent disadvantages of ligament and capsular dissection, blood vessels damage. This study introduces a novel measures of percutaneous screw fixation for acute scaphoid fractures. We used one K-wire maintaining the reduction of the scaphoid fractures throughout the entire process of drilling and screw insertion and screw fixation for acute scaphoid fractures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hand, Wrist, Wounds and Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    open reduction group
    Arm Type
    Placebo Comparator
    Arm Title
    percutaneous group
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Percutaneous screw fixation through K-wire-assisted reduction and maintenance
    Intervention Description
    Percutaneous screw fixation for acute scaphoid fractures through K-wire-assisted reduction and maintenance
    Primary Outcome Measure Information:
    Title
    The modified Mayo wrist scoring system
    Description
    The function outcomes including pain, work status, range of motion (Rom) and grip strength were assessed and graded as excellent, good , fair and poor.
    Time Frame
    3 months

    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: acute scaphoid fractures Injury to surgery less than 7 days Only one injured hand Written informed consent to undergo the surgical procedure Patients of either sex aged between 18 and 70 years Exclusion Criteria: Patients with vascular injuried requiring revascularization Concomitant phalanx fractures or other injuries needing immobilization Loss of skin substance requiring grafts or flaps Uncompensated diabetes, neoplasia, haemocoagulative alterations, psychic disorders Smokers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chunjie Liu, M.D.
    Organizational Affiliation
    Hebei Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
    Citations:
    PubMed Identifier
    29318360
    Citation
    Yu Y, Cui H, Yang X, Yu X, Bai Y. A novel percutaneous achievement and maintenance of reduction and screw fixation for acute displaced scaphoid fractures: minimum two-year follow-up. Int Orthop. 2018 Aug;42(8):1911-1916. doi: 10.1007/s00264-018-3758-5. Epub 2018 Jan 10.
    Results Reference
    background
    PubMed Identifier
    18656774
    Citation
    Merrell G, Slade J. Technique for percutaneous fixation of displaced and nondisplaced acute scaphoid fractures and select nonunions. J Hand Surg Am. 2008 Jul-Aug;33(6):966-73. doi: 10.1016/j.jhsa.2008.04.023.
    Results Reference
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    PubMed Identifier
    31543293
    Citation
    Morsy M, Sabbagh MD, van Alphen NA, Laungani AT, Kadar A, Moran SL. The Vascular Anatomy of the Scaphoid: New Discoveries Using Micro-Computed Tomography Imaging. J Hand Surg Am. 2019 Nov;44(11):928-938. doi: 10.1016/j.jhsa.2019.08.001. Epub 2019 Sep 19.
    Results Reference
    background
    PubMed Identifier
    24651287
    Citation
    Garcia RM, Ruch DS. Management of scaphoid fractures in the athlete: open and percutaneous fixation. Sports Med Arthrosc Rev. 2014 Mar;22(1):22-8. doi: 10.1097/JSA.0000000000000008.
    Results Reference
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    Percutaneous Screw Fixation for Acute Scaphoid Fractures Through K-wire-assisted Reduction and Maintenance

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