Distal Radial Fractures in the Late Middle Aged (RIST)
|ClinicalTrials.gov Identifier: NCT02353338|
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : January 24, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- Recruitment and eligibility rates [ Time Frame: 1 year ]
- Patient Rated Wrist-Evaluation (PRWE) questionnaire [ Time Frame: baseline, 6 weeks, 3 months, 6 months, and 12 months ]
- Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months ]
- Visual Analogue Scale (VAS) for cosmesis [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
- Visual Analogue Scale (VAS) for pain [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months ]
- Grip Strength (Hand held dynamometer) [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months ]
- Range of Motion (Goniometry) [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months ]
- Radiographic measures (Doral angulation, ulnar shortening, articular steps and gaps) [ Time Frame: baseline, 6 weeks, 3 months, 6 months, 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353338
|Sturgeon Community Hospital|
|St. Albert, Alberta, Canada, T8N 6C4|