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Clinical Trials/NCT04482868
NCT04482868CompletedNot Applicable

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

Hebei Medical University0 sites20 target enrollmentStarted: January 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Primary Endpoint
The modified Mayo wrist scoring system

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

The modified Mayo wrist scoring system

Time Frame: 3 months

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chunjie Liu

Chief physician

Hebei Medical University

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