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

NCT04482868 | Completed DMC

• 1 other identifier: 2017-09-03
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

open reduction group

PLACEBO COMPARATOR

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

percutaneous group

EXPERIMENTAL

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

Interventions

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

open reduction group; percutaneous group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University: lead

Related Publications (4)

• 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.

  PMID: 29318360 BACKGROUND

• 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.

  PMID: 18656774 BACKGROUND

• 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.

  PMID: 31543293 BACKGROUND

• 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.

  PMID: 24651287 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Maintenance

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Chunjie Liu, M.D.

  Hebei Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 19, 2020
• First Posted: July 23, 2020
• Study Start: January 1, 2015
• Primary Completion: September 6, 2018
• Study Completion: December 29, 2018
• Last Updated: August 14, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR