Treatment of Distal Radius Fractures in Elderly Patients - Full Text View

Sponsors and Collaborators:	Hand and Upper Limb Clinic, Canada LHRI- Lawson Health Research Institute
Information provided by:	Hand and Upper Limb Clinic, Canada
ClinicalTrials.gov Identifier:	NCT00788190

Purpose

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.

Condition	Intervention
Distal Radius Fractures	Procedure: Distal Radius Fracture Reduction Other: Conservative Management

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Treatment of Distal Radius Fractures in Elderly Patients, a Randomized Controlled Trial

Further study details as provided by Hand and Upper Limb Clinic, Canada:

Primary Outcome Measures:

Primary: Patient pain and disability. Will be quantified with Disabilities of the Arm and Shoulder (DASH) and Patient Rated Wrist Evaluation (PRWE). [ Time Frame: 0-1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: over 1 year ] [ Designated as safety issue: No ]
Secondary: To stratify results by age. (65-75, 77-80, and >80) [ Time Frame: 0-1 year ] [ Designated as safety issue: No ]
Grip strength, Range of Motion and Dexterity testing of wrists [ Time Frame: 3 months to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	65
Study Start Date:	November 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Surgery Surgical intervention to reduce Distal Radius Fracture	Procedure: Distal Radius Fracture Reduction Surgical Intervention to Reduce Distal Radius Fracture
Conservative Treatment Conservative treatment of Distal Radius Fractures	Other: Conservative Management Conservative management of Distal Radius Fractures

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788190

Contacts

Contact: Joy C Macdermid, Phd	519-646-6100 ext 64636	jmacderm@uwo.ca
Contact: Ruby Grewal, MD	519-646-6286	rgrewa@uwo.ca

Locations

Canada, Ontario
Hand and upper Limb Centre	Recruiting
London, Ontario, Canada, N6A5L8
Contact: Joy C MacDermid, PhD 519-646-6100 ext 64636 jmacderm@uwo.ca
Contact: Chris A Young, B.A. Kin 519-646-6100 ext 64875 chris.young@sjhc.london.on.ca
Principal Investigator: Ruby Grewal, MD, FRCSC
Principal Investigator: Joy C MacDermid, PhD
Hand and Upper Limb Centre	Recruiting
London, Ontario, Canada, N6A4L6
Contact: Joy MacDermid, PhD 519-646-6100 ext 64636

Sponsors and Collaborators

Hand and Upper Limb Clinic, Canada

LHRI- Lawson Health Research Institute

Investigators

Principal Investigator:	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

More Information

Responsible Party:	St. Joseph's hospital ( Dr. Joy MacDermid, Associate Professor )
Study ID Numbers:	LHRI 001
Study First Received:	November 7, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00788190
Health Authority:	Canada: UWO Ethics Board

Keywords provided by Hand and Upper Limb Clinic, Canada:

Distal Radius Fracture
Elderly
Prospective randomized trial
Outcomes

Pain and Function
Surgical Vs. conservative management
Fractures with borderline alignment

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Forearm Injuries
Disorders of Environmental Origin

Pain
Radius Fractures
Arm Injuries

ClinicalTrials.gov processed this record on January 16, 2009