Treatment of Distal Radius Fractures in Elderly Patients

This study has been withdrawn prior to enrollment.
(The inclusion/Exclusion criteria was too strict which restricted recruitment)
Sponsor:
Collaborator:
LHRI- Lawson Health Research Institute
Information provided by:
Hand and Upper Limb Clinic, Canada
ClinicalTrials.gov Identifier:
NCT00788190
First received: November 7, 2008
Last updated: April 7, 2011
Last verified: November 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Treatment of Distal Radius Fractures in Elderly Patients, a Randomized Controlled Trial

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Hand and upper Limb Centre
London, Ontario, Canada, N6A5L8
Hand and Upper Limb Centre
London, Ontario, Canada, N6A4L6
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

No publications provided

Responsible Party: Dr. Joy MacDermid, Associate Professor, St. Joseph's hospital
ClinicalTrials.gov Identifier: NCT00788190     History of Changes
Other Study ID Numbers: LHRI 001
Study First Received: November 7, 2008
Last Updated: April 7, 2011
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

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on July 29, 2014