Treatment of Distal Radius Fractures in Elderly Patients

Not Applicable

Withdrawn

• Conditions: Distal Radius Fractures
• Interventions: Procedure: Distal Radius Fracture Reduction; Other: Conservative Management

• Registration Number: NCT00788190
• Lead Sponsor: Hand and Upper Limb Clinic, Canada

Brief Summary

The purpose of this study is to create and test a treatment algorithm to guide the treatment of distal radius fractures in patients 65 and older and to obtain level-one evidence to determine the best method of treating distal radius fractures in this growing population demographic.

Detailed Description

* Distal radius fractures with borderline alignment will be randomized to surgical intervention or conservative treatment.

* Patients will fill out subjective questionnaires at 0, 6weeks, 3months, 6 months, and 1 year.

* Patients will perform objective strength tests, dexterity tests and have their range of motion tested at 12 weeks, 6 months and 12 months.

Study Timeline

• Status Verified: 2008-11
• Study Start: 2008-11
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Distal Radius Fracture
• Between 10 and 20 degrees of dorsal angulation
• Between 3 and 5mm of Ulnar positive variance
• Between 1 and 2mm intra Articular Step deformity
• Age 65 and older

Exclusion Criteria

• Pre-Morbid medical conditions which preclude surgical intervention
• Patients who do not live independently.
• Patients with an open fracture
• Associated soft tissue or skeletal injury to the same limb.
• Pre-existing wrist arthrosis or disability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Distal Radius Fracture Reduction	Surgical intervention to reduce Distal Radius Fracture
Conservative Treatment	Conservative Management	Conservative treatment of Distal Radius Fractures

Primary Outcome Measures

Name	Time	Method
Primary: Patient pain and disability. Will be quantified with Disabilities of the Arm and Shoulder (DASH) and Patient Rated Wrist Evaluation (PRWE).	0-1 year

Secondary Outcome Measures

Name	Time	Method
Secondary: To determine if other baseline factors influence outcome. For example, baseline activity levels (RAPA), home supports, hand dominance, and general mental health will be analyzed.	over 1 year
Secondary: To stratify results by age. (65-75, 77-80, and >80)	0-1 year
Grip strength, Range of Motion and Dexterity testing of wrists	3 months to 12 months

Trial Locations

Locations (2)

Hand and Upper Limb Centre; 🇨🇦 London, Ontario, Canada

Hand and upper Limb Centre; 🇨🇦 London, Ontario, Canada