Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

NCT01268397 | Unknown

• 1 other identifier: Wilcke-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.

Conditions

Fracture of the Distal Radius; Wrist Fracture

Keywords

elderly; wrist fracture; fracture of the distal radius; volar plate; plaster cast

Outcome Measures

Primary Outcomes (1)

• patient-perceived disability measured by the PRWE and DASH questionnaires

  one year after wrist fracture

Secondary Outcomes (1)

• impairments (grip strength and range of motion compared with the uninjured wrist)

  one year after wrist fracture

Study Arms (2)

ORIF

ACTIVE COMPARATOR

Open reduction and internal fixation with a volar plate

Procedure: open reduction and internal fixation with a volar plate

plaster treatment

ACTIVE COMPARATOR

Closed reduction and plaster treatment

Procedure: closed reduction and plaster treatment

Interventions

open reduction and internal fixation with a volar plate PROCEDURE

flexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion

Also known as: plate: Königsee or Aculoc from Swemac, Sweden

ORIF

closed reduction and plaster treatment PROCEDURE

closed reduction, below elbow plaster cast, semicircular for 5 week

plaster treatment

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).

You may not qualify if:

• Previous displaced fracture of the distal radius.
• Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ\<5), psychiatric illness, alcohol abuse).

Sponsors & Collaborators

• Danderyd Hospital: lead
• Stockholm South General Hospital: collaborator

Study Sites (1)

Division of Orthopaedics Danderyd Hospital

Stockholm, S-18288, 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

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Per Y Adolphson, MD, PhD

  Karolinska Institute at Danderyd Hospital

  STUDY DIRECTOR

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: MD

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: December 30, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2019
• Last Updated: February 8, 2019

Record last verified: 2018-04

Locations

SE (1)