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OpenTrials
Completed

NCT Number: NCT04482868

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Percutaneous screw fixation for acute scaphoid fractures through K-wire-assisted reduction and maintenance

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hebei Medical University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2020
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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