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Distal Radial Fractures in the Late Middle Aged (RIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353338
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Shoulder & Upper Extremity Research Group of Edmonton

Brief Summary:

Background: Wrist fractures are a common injury among people aged 55-70. The radius is one of the bones making up the wrist joint, and is typically the site of injury in a broken wrist. Methods of treating a broken radius include placing the wrist in a cast for 6 weeks (conservative management) or receiving surgery. Surgery allows for earlier movement of the wrist and return to activity, while being placed in a cast is less invasive than surgery.

Surgery to fix these fractures has become more common; however there is little agreement about who should receive surgery and who should be placed in a cast to heal. The goal of this study is to compare outcomes between people aged 55-70 who have broken their wrist and had surgery, and those who received a cast.

Procedures: Participants in this study will be randomly assigned to one of two study groups within 1 week of injury at their first clinic visit with the surgeon.

Patients in Group A (surgical management) will continue with casting for a total of 6 weeks, as indicated by the surgeon.

Patients in Group B (conservative management) will receive surgery, and the attending surgeon will determine the best fracture fixation method for the wrist.

The research coordinator will assess the injured wrist at 6 weeks, 3, 6, and 12 months after the initial injury. At each assessment, the wrist will be examined and participants will be asked to fill in some questionnaires about health, pain, wrist function, and satisfaction with the wrist. An X-ray will also be performed on the wrist to assess bone healing. Information from each visit will be used to determine how participants are doing and to compare the 2 study groups.


Condition or disease Intervention/treatment Phase
Radius Fracture Procedure: Surgical intervention Procedure: Conservative management Device: cast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Distal Radial Fractures in the Late Middle Aged: Surgical or Conservative Treatment - A Randomized Control Trial
Actual Study Start Date : May 22, 2015
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : September 21, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A: Surgical
Individuals in Group A will receive surgery to correct their radial fracture
Procedure: Surgical intervention
Surgical management of radial fracture

Active Comparator: Group B: Conservative Treatment
Individuals in Group B will be immobilized in a cast, as per usual standard of conservative treatment.
Procedure: Conservative management
Immobilized/cast for 6 weeks

Device: cast



Primary Outcome Measures :
  1. Recruitment and eligibility rates [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Patient Rated Wrist-Evaluation (PRWE) questionnaire [ Time Frame: baseline, 6 weeks, 3 months, 6 months, and 12 months ]
  2. Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months ]
  3. Visual Analogue Scale (VAS) for cosmesis [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
  4. Visual Analogue Scale (VAS) for pain [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months ]
  5. Grip Strength (Hand held dynamometer) [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months ]
  6. Range of Motion (Goniometry) [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months ]
  7. Radiographic measures (Doral angulation, ulnar shortening, articular steps and gaps) [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months ]


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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 55-70 and have had a distal radial fracture
  2. The following radiographic findings before reduction: dorsal angulation ≤30 degrees, ulnar shortening ≤5 mm relative to the contralateral side (subjects will have contralateral wrist xrays), articular step ≤2 mm after initial post reduction and gap ≤5 mm

Exclusion Criteria:

  1. patients with volarly displaced intra and extra articular fractures (Barton and Smith's)
  2. radiocarpal subluxation or dislocation
  3. open fractures
  4. ipsilateral upper-extremity injuries
  5. bilateral or multiple traumas

5) previous injury to the contralateral wrist

6) those deemed not suitable for surgical management (as indicated and documented by surgeon and research coordinator)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353338


Locations
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Canada, Alberta
Sturgeon Community Hospital
St. Albert, Alberta, Canada, T8N 6C4
Sponsors and Collaborators
Shoulder & Upper Extremity Research Group of Edmonton
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Responsible Party: Shoulder & Upper Extremity Research Group of Edmonton
ClinicalTrials.gov Identifier: NCT02353338    
Other Study ID Numbers: RES0025250
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: May 2018
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries