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

Distal Radius Fracture Clinical Trial

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Official title:

Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154620
• Other study ID #: 70
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: January 31, 2018

Study information

• Verified date: March 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 31, 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.

• Low energy injury

• Patient 70 years old or older

• 72 hours or less since injury at time of diagnosis

• Patient registered in the Stockholm region

• Patient understands spoken and written swedish

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Volar plate
An anatomically countoured volar plate is implanted through a Henry's incision.

Device:
• Synthes TCP volar plate

Locations

Country	Name	City	State
Sweden	Department of Orthopaedics, Stockholm South Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient related wrist evaluation (PRWE)		52 weeks
Secondary	Patient related wrist evaluation (PRWE)		3 years