Radius; Fracture, Lower or Distal End
Conditions
Keywords
Wrist fracture, Radius fracture, Elderly, Splint, Cast
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.
Interventions
DEVICECast made of generic plaster or fiberglass cast material
Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture.
DEVICEGeneric off the shelf removable splint
Patients will be randomized to receive a generic off the shelf removable splint for treatment of a non-displaced distal radius fracture.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Colles' Fracture - Distal radius fracture with dorsal angulation, apex volar (satisfies non-operative radiographic criteria before or after reduction 2. Isolated upper limb injury 3. No previous wrist fracture 4. Available for follow-up 5. Between 60 and 100 years of age
Exclusion criteria
1. Less than 60 years of age 2. Fractures that do not meet non-operative criteria or are deemed unstable by surgeon, subsequently requiring surgery after first clinic visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Mayo Wrist Score | 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. |
| Complication Rate | 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. |
| Mean Pain Score | 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. |
| Change in Wrist Range of Motion (ROM) | Baseline, Month 3 | Wrist ROM will be assessed by a goniometer exam. |
| Change in Grip Strength | Baseline, Month 3 | Grip strength will be assessed by bilateral dynamometer testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SF-12 QOL | 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. |
| Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Emory Orthopaedic Fracture Clinic from April 2014 to November 2014.
Participants by arm
| Arm | Count |
|---|---|
| Generic Plaster or Fiberglass Cast Group Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks. | 1 |
| Generic Off the Shelf Removable Splint Group Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks. | 4 |
| Total | 5 |
Baseline characteristics
| Characteristic | Generic Plaster or Fiberglass Cast Group | Generic Off the Shelf Removable Splint Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 4 |
| other Total, other adverse events | 0 / 1 | 0 / 4 |
| serious Total, serious adverse events | 0 / 1 | 0 / 4 |
Outcome results
Primary
Change in Grip Strength
Grip strength will be assessed by bilateral dynamometer testing.
Time frame: Baseline, Month 3
Population: Data for this outcome measure are not available for analysis.
Primary
Change in Wrist Range of Motion (ROM)
Wrist ROM will be assessed by a goniometer exam.
Time frame: Baseline, Month 3
Population: Data for this outcome measure are not available for analysis.
Primary
Complication Rate
The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.
Time frame: Duration of Study (Up to 3 Months)
Population: Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Generic Plaster or Fiberglass Cast Group | Complication Rate | 0 Participants |
Primary
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.
Time frame: Baseline, Week 2, Week 6, Week 12
Population: Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Generic Plaster or Fiberglass Cast Group | Mean Mayo Wrist Score | Baseline | 31.67 units on a scale | Standard Deviation 16.07 |
| Generic Plaster or Fiberglass Cast Group | Mean Mayo Wrist Score | Week 2 | 46.67 units on a scale | Standard Deviation 20.21 |
| Generic Plaster or Fiberglass Cast Group | Mean Mayo Wrist Score | Week 6 | 65 units on a scale | Standard Deviation 10 |
| Generic Plaster or Fiberglass Cast Group | Mean Mayo Wrist Score | Week 12 | 78.33 units on a scale | Standard Deviation 2.89 |
Primary
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.
Time frame: Baseline, Week 2, Week 6, Week 12
Population: Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Generic Plaster or Fiberglass Cast Group | Mean Pain Score | Baseline | 6 units on a scale | Standard Deviation 3.46 |
| Generic Plaster or Fiberglass Cast Group | Mean Pain Score | Week 2 | 3.66 units on a scale | Standard Deviation 3.06 |
| Generic Plaster or Fiberglass Cast Group | Mean Pain Score | Week 6 | 1.67 units on a scale | Standard Deviation 1.53 |
| Generic Plaster or Fiberglass Cast Group | Mean Pain Score | Week 12 | .33 units on a scale | Standard Deviation 0.58 |
Secondary
Change in SF-12 QOL
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.
Time frame: Baseline, Month 3
Population: No participants completed this survey as this outcome measure was removed from the protocol. No data were collected.
Secondary
Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score
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.
Time frame: Baseline, Week 2, Week 6, Week 12
Population: Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Generic Plaster or Fiberglass Cast Group | Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score | Baseline | 73.03 units on a scale | Standard Deviation 23.53 |
| Generic Plaster or Fiberglass Cast Group | Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score | Week 2 | 38.63 units on a scale | Standard Deviation 27.11 |
| Generic Plaster or Fiberglass Cast Group | Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score | Week 6 | 23.33 units on a scale | Standard Deviation 22.5 |
| Generic Plaster or Fiberglass Cast Group | Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score | Week 12 | 11.67 units on a scale | Standard Deviation 16.07 |