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
About this trial
This is an interventional treatment trial for Hand
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
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
NCT ID
NCT04482868
First Posted
July 19, 2020
Last Updated
August 12, 2020
Sponsor
Hebei Medical University
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
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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
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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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