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Treatment of Distal Radius Fractures in Elderly Patients

Primary Purpose

Distal Radius Fractures

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Distal Radius Fracture Reduction
Conservative Management
Sponsored by
Hand and Upper Limb Clinic, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Distal Radius Fractures focused on measuring Distal Radius Fracture, Elderly, Prospective randomized trial, Outcomes, Pain and Function, Surgical Vs. conservative management, Fractures with borderline alignment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hand and Upper Limb Centre
  • Hand and upper Limb Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Surgery

Conservative Treatment

Arm Description

Surgical intervention to reduce Distal Radius Fracture

Conservative treatment of Distal Radius Fractures

Outcomes

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).

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.
Secondary: To stratify results by age. (65-75, 77-80, and >80)
Grip strength, Range of Motion and Dexterity testing of wrists

Full Information

First Posted
November 7, 2008
Last Updated
April 7, 2011
Sponsor
Hand and Upper Limb Clinic, Canada
Collaborators
LHRI- Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00788190
Brief Title
Treatment of Distal Radius Fractures in Elderly Patients
Official Title
Treatment of Distal Radius Fractures in Elderly Patients, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Withdrawn
Why Stopped
The inclusion/Exclusion criteria was too strict which restricted recruitment
Study Start Date
November 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hand and Upper Limb Clinic, Canada
Collaborators
LHRI- Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
Keywords
Distal Radius Fracture, Elderly, Prospective randomized trial, Outcomes, Pain and Function, Surgical Vs. conservative management, Fractures with borderline alignment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Other
Arm Description
Surgical intervention to reduce Distal Radius Fracture
Arm Title
Conservative Treatment
Arm Type
Other
Arm Description
Conservative treatment of Distal Radius Fractures
Intervention Type
Procedure
Intervention Name(s)
Distal Radius Fracture Reduction
Other Intervention Name(s)
Distal Radius Reduction
Intervention Description
Surgical Intervention to Reduce Distal Radius Fracture
Intervention Type
Other
Intervention Name(s)
Conservative Management
Intervention Description
Conservative management of Distal Radius Fractures
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Secondary: To stratify results by age. (65-75, 77-80, and >80)
Time Frame
0-1 year
Title
Grip strength, Range of Motion and Dexterity testing of wrists
Time Frame
3 months to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy C MacDermid, PhD
Organizational Affiliation
Hand and Upper Limb Centre, St. Joseph's Health Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruby Grewal, MD, FRCSC
Organizational Affiliation
Hand and Upper Limb Centre, St Joseph's Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hand and Upper Limb Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4L6
Country
Canada
Facility Name
Hand and upper Limb Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5L8
Country
Canada

12. IPD Sharing Statement

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Treatment of Distal Radius Fractures in Elderly Patients

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