Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster

NCT02154620 | Completed DMC

• 1 other identifier: 70
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination. An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study. A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.

Conditions

Distal Radius Fracture

Keywords

Distal radius fracture; wrist fracture; volar plate; surgical treatment; plaster immobilisation

Outcome Measures

Primary Outcomes (1)

• Patient related wrist evaluation (PRWE)

  52 weeks

Secondary Outcomes (1)

• Patient related wrist evaluation (PRWE)

  3 years

Study Arms (2)

Plaster cast

NO INTERVENTION

The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist

Volar plate

EXPERIMENTAL

The patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery.

Procedure: Volar plate; Device: Synthes TCP volar plate

Interventions

Volar plate PROCEDURE

An anatomically countoured volar plate is implanted through a Henry's incision.

Also known as: Synthes TCP volar plate for distal radius

Volar plate

Synthes TCP volar plate DEVICE

Volar plate

Eligibility Criteria

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

You may qualify if:

• Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
• Low energy injury
• Patient 70 years old or older
• hours or less since injury at time of diagnosis
• Patient registered in the Stockholm region
• Patient understands spoken and written swedish

You may not qualify if:

• Intraarticular displacement in radiocarpal joint of more than 1 mm
• Ulna fractured proximal to the base of the styloid process of ulna
• Earlier unilateral functional impairment of hand/wrist
• Injury to tendon, nerve or skin besides the fracture
• Rheumatoid arthritis or other severe systemic joint disease
• Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)
• Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle
• Medical illness that makes general anesthesia impossible

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Orthopaedics, Stockholm South Hospital

Stockholm, 11883, Sweden

Location

Related Publications (1)

• Sudow H, Severin S, Wilcke M, Saving J, Skoldenberg O, Navarro CM. Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years - a three year follow-up of a randomized controlled trial. BMC Musculoskelet Disord. 2022 May 12;23(1):447. doi: 10.1186/s12891-022-05394-7.

  PMID: 35549696 DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Anders Enocson, M.D, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: June 3, 2014
• Study Start: April 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 31, 2018
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

SE (1)