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

NCT02066857 | Completed Results

• 1 other identifier: IRB00071060
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radius; Fracture, Lower or Distal End

Keywords

Wrist fracture; Radius fracture; Elderly; Splint; Cast

Outcome Measures

Primary Outcomes (5)

• Change in Wrist Range of Motion (ROM)

  Wrist ROM will be assessed by a goniometer exam.

  Baseline, Month 3

• Mean Mayo Wrist Score

  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.

  Baseline, Week 2, Week 6, Week 12

• Change in Grip Strength

  Grip strength will be assessed by bilateral dynamometer testing.

  Baseline, Month 3

• Complication Rate

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

  Duration of Study (Up to 3 Months)

• Mean Pain Score

  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.

  Baseline, Week 2, Week 6, Week 12

Secondary Outcomes (2)

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

  Baseline, Week 2, Week 6, Week 12

• Change in SF-12 QOL

  Baseline, Month 3

Study Arms (2)

Generic plaster or fiberglass cast group

ACTIVE COMPARATOR

Patients will be randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.

Device: Cast made of generic plaster or fiberglass cast material

Generic "off the shelf" removable splint group

ACTIVE COMPARATOR

Subjects will be randomized and receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.

Device: Generic "off the shelf" removable splint

Interventions

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.

Also known as: No brand name applicable.

Generic plaster or fiberglass cast group

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.

Also known as: No brand name applicable

Generic "off the shelf" removable splint group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Wrist Fractures; Radius Fractures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Wrist Injuries; Arm Injuries; Forearm Injuries

Limitations and Caveats

A small number of participants was analyzed due to limited enrollment and completion rates.

Results Point of Contact

• Title: Claude Jarrett, M.D.
• Organization: Emory University

CJarrett@wilmingtonhealth.com

404-778-8099

Study Officials

• Claudius Jarrett, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedics

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 20, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 24, 2017
• Results First Posted: May 24, 2017

Record last verified: 2017-05

Locations

US (1)