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

NCT ID: NCT04482868

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2018-12-29

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.

Conditions

Hand; Wrist; Wounds and Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

open reduction group

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: PROCEDURE

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

percutaneous group

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Interventions

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

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chunjie Liu

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chunjie Liu, M.D.

Role: STUDY_CHAIR

Hebei Medical University

References

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.

Reference Type: BACKGROUND

PMID: 29318360 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18656774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31543293 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24651287 (View on PubMed)

Other Identifiers

2017-09-03

Identifier Type: -

Identifier Source: org_study_id