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

H

Hebei Medical University

Status

Completed

Conditions

Wrist
Hand
Wounds and Injuries

Treatments

Procedure: Percutaneous screw fixation through K-wire-assisted reduction and maintenance

Study type

Interventional

Funder types

Other

Identifiers

NCT04482868
2017-09-03

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups, including a placebo group

open reduction group
Placebo Comparator group
Treatment:
Procedure: Percutaneous screw fixation through K-wire-assisted reduction and maintenance
percutaneous group
Experimental group
Treatment:
Procedure: Percutaneous screw fixation through K-wire-assisted reduction and maintenance

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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