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Completed

NCT Number: NCT02066857

Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly

The purpose of this prospective randomized study is to add to the body of knowledge on the treatment of minimally displaced distal radius fractures in patients over 60 years of age. The investigators believe that treating minimally displaced distal radius fractures in people over 60 with a removable splint and early range of motion will provide greater patient satisfaction, fewer complications, and earlier functional returns to pre-injury for these patients compared to those treated with a short arm cast which immobilizes the limb for at least four weeks, and has been shown to lead to longer recovery and possible residual stiffness. The investigators hope to provide sufficient evidence in directing treatment that will give the most efficacious and the most satisfactory return of prior function to patients. Since distal radius fractures in the elderly are common because of poorer bone quality, the elderly proportion of the population is increasing, and controlling health costs is of current concern, answering the question of which treatment produces the best results for all these concerns is of increasing importance now.

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Key information

Conditions

Radius; Fracture, Lower or Distal End Arm Injuries Forearm Injuries Fractures, Bone Radius Fractures Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Colles' Fracture - Distal radius fracture with dorsal angulation, apex volar (satisfies non-operative radiographic criteria before or after reduction
  • Isolated upper limb injury
  • No previous wrist fracture
  • Available for follow-up
  • Between 60 and 100 years of age

Exclusion criteria

  • Less than 60 years of age
  • Fractures that do not meet non-operative criteria or are deemed unstable by surgeon, subsequently requiring surgery after first clinic visit.

Treatment and study plan

Cast made of generic plaster or fiberglass cast material

Device

Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture.

Other names: No brand name applicable.

Generic "off the shelf" removable splint

Device

Patients will be randomized to receive a generic "off the shelf" removable splint for treatment of a non-displaced distal radius fracture.

Other names: No brand name applicable

Primary outcomes

  1. Change in Wrist Range of Motion (ROM)

    Time frame: Baseline, Month 3

    Wrist ROM will be assessed by a goniometer exam.

  2. Mean Mayo Wrist Score

    Time frame: Baseline, Week 2, Week 6, Week 12

    The Mayo Wrist Score is a clinician-completed scoring system used to evaluate the level of functionality in the wrist, assessing pain, functional status (able to work), range of motion and grip strength. Total scores for functionality range from 0-100 and are categorized as follows: 90-100 indicates excellent, 80-90 indicates good, 60-80 indicates satisfactory, below 60 indicates poor. The assessment was completed at all study visits.

  3. Change in Grip Strength

    Time frame: Baseline, Month 3

    Grip strength will be assessed by bilateral dynamometer testing.

  4. Complication Rate

    Time frame: Duration of Study (Up to 3 Months)

    The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.

  5. Mean Pain Score

    Time frame: Baseline, Week 2, Week 6, Week 12

    Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing "no pain" and 10 representing "the worst pain imaginable". The assessment was completed at all study visits.

Secondary outcomes

  1. Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score

    Time frame: Baseline, Week 2, Week 6, Week 12

    The DASH questionnaire asks about symptoms as well as ability to perform certain activities. Scores range on a 0-100 scale. A higher score indicates greater disability.

  2. Change in SF-12 QOL

    Time frame: Baseline, Month 3

    The SF-12 QOL is a self-administered measure asking views about participant's health and how well they are able to perform usual activities.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Use of Cast Versus Removable Splints for Minimally Displaced Distal Radius Fractures in Elderly Patients: A Prospective, Randomized Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2014
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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