Treatment of Distal Radius Fractures in Elderly Patients

Distal Radius Fractures Clinical Trial

Official title:

Treatment of Distal Radius Fractures in Elderly Patients, a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00788190
• Other study ID #: LHRI 001
• Status: Withdrawn
• Phase: N/A
• First received: November 7, 2008
• Last updated: April 7, 2011
• Start date: November 2008

Study information

• Verified date: November 2008
• Source: Hand and Upper Limb Clinic, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: UWO Ethics Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 65
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Distal Radius Fracture Reduction
Surgical Intervention to Reduce Distal Radius Fracture

Other:
• Conservative Management
Conservative management of Distal Radius Fractures

Locations

Country	Name	City	State
Canada	Hand and Upper Limb Centre	London	Ontario
Canada	Hand and upper Limb Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hand and Upper Limb Clinic, Canada	LHRI- Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Secondary: To stratify results by age. (65-75, 77-80, and >80)		0-1 year	No
Secondary	Grip strength, Range of Motion and Dexterity testing of wrists		3 months to 12 months	No