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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482868
• Other study ID #: 2017-09-03
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 29, 2018

Study information

• Verified date: August 2020
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 29, 2018
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand
• Wounds and Injuries
• Wrist

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

References & Publications (4)

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. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months