Treatment of Distal Radius Fractures in Elderly Patients

NCT00788190 | Withdrawn

• 1 other identifier: LHRI 001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Distal Radius Fractures

Keywords

Distal Radius Fracture; Elderly; Prospective randomized trial; Outcomes; Pain and Function; Surgical Vs. conservative management; Fractures with borderline alignment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Surgery

OTHER

Surgical intervention to reduce Distal Radius Fracture

Procedure: Distal Radius Fracture Reduction

Conservative Treatment

OTHER

Conservative treatment of Distal Radius Fractures

Other: Conservative Management

Interventions

Distal Radius Fracture Reduction PROCEDURE

Surgical Intervention to Reduce Distal Radius Fracture

Also known as: Distal Radius Reduction

Surgery

Conservative Management OTHER

Conservative management of Distal Radius Fractures

Conservative Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hand and Upper Limb Clinic, Canada: lead
• LHRI- Lawson Health Research Institute: collaborator

Study Sites (2)

Hand and Upper Limb Centre

London, Ontario, N6A4L6, Canada

Location

Hand and upper Limb Centre

London, Ontario, N6A5L8, Canada

Location

MeSH Terms

Conditions

Wrist Fractures; Pain

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Joy C MacDermid, PhD

  Hand and Upper Limb Centre, St. Joseph's Health Care

  PRINCIPAL INVESTIGATOR

• Ruby Grewal, MD, FRCSC

  Hand and Upper Limb Centre, St Joseph's Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 10, 2008
• Study Start: November 1, 2008
• Last Updated: April 11, 2011

Record last verified: 2008-11

Locations

CA (2)