Distal Radial Fractures in the Late Middle Aged

NCT02353338 | Completed

• 1 other identifier: RES0025250
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Radius Fracture

Outcome Measures

Primary Outcomes (1)

• Recruitment and eligibility rates

  1 year

Secondary Outcomes (7)

• Patient Rated Wrist-Evaluation (PRWE) questionnaire

  baseline, 6 weeks, 3 months, 6 months, and 12 months

• Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire

  baseline, 6 weeks, 3 months, 6 months, 12 months

• Visual Analogue Scale (VAS) for cosmesis

  6 weeks, 3 months, 6 months, 12 months

• Visual Analogue Scale (VAS) for pain

  baseline, 6 weeks, 3 months, 6 months, 12 months

• Grip Strength (Hand held dynamometer)

  baseline, 6 weeks, 3 months, 6 months, 12 months

Study Arms (2)

Group A: Surgical

EXPERIMENTAL

Individuals in Group A will receive surgery to correct their radial fracture

Procedure: Surgical intervention

Group B: Conservative Treatment

ACTIVE COMPARATOR

Individuals in Group B will be immobilized in a cast, as per usual standard of conservative treatment.

Procedure: Conservative management; Device: cast

Interventions

Surgical intervention PROCEDURE

Surgical management of radial fracture

Group A: Surgical

Conservative management PROCEDURE

Immobilized/cast for 6 weeks

Group B: Conservative Treatment

cast DEVICE

Group B: Conservative Treatment

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 55-70 and have had a distal radial fracture
• 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

You may not qualify if:

• patients with volarly displaced intra and extra articular fractures (Barton and Smith's)
• radiocarpal subluxation or dislocation
• open fractures
• ipsilateral upper-extremity injuries
• bilateral or multiple traumas
• \) previous injury to the contralateral wrist
• \) those deemed not suitable for surgical management (as indicated and documented by surgeon and research coordinator)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Sturgeon Community Hospital

St. Albert, Alberta, T8N 6C4, Canada

Location

MeSH Terms

Conditions

Radius Fractures

Interventions

Surgical Procedures, Operative; Conservative Treatment; Casts, Surgical

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Therapeutics; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 2, 2015
• Study Start: May 22, 2015
• Primary Completion: October 31, 2017
• Study Completion: September 21, 2018
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

CA (1)