Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

NCT ID: NCT01268397

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2019-12-31

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.

Detailed Description

We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.

Conditions

Fracture of the Distal Radius; Wrist Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ORIF

Open reduction and internal fixation with a volar plate

Group Type: ACTIVE_COMPARATOR

open reduction and internal fixation with a volar plate

Intervention Type: PROCEDURE

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

plaster treatment

Closed reduction and plaster treatment

Group Type: ACTIVE_COMPARATOR

closed reduction and plaster treatment

Intervention Type: PROCEDURE

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

Interventions

open reduction and internal fixation with a volar plate

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

Intervention Type: PROCEDURE

closed reduction and plaster treatment

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

Intervention Type: PROCEDURE

Other Intervention Names

plate: Königsee or Aculoc from Swemac, Sweden

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stockholm South General Hospital

OTHER

Sponsor Role: collaborator

Danderyd Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sara Severin Wahlgren

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Per Y Adolphson, MD, PhD

Role: STUDY_DIRECTOR

Karolinska Institute at Danderyd Hospital

Locations

Division of Orthopaedics Danderyd Hospital

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 35549696 (View on PubMed)

Other Identifiers

Wilcke-02

Identifier Type: -

Identifier Source: org_study_id