Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 2, Week 6, Week 12 |
| Change in SF-12 QOL |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claudius Jarrett, M.D. | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Orthopaedics and Spine Center | Atlanta | Georgia | 30329 | United States |
Not provided
Participants were recruited from the Emory Orthopaedic Fracture Clinic from April 2014 to November 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Generic "Off the Shelf" Removable Splint Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Wrist Range of Motion (ROM) | Wrist ROM will be assessed by a goniometer exam. | Data for this outcome measure are not available for analysis. | Posted | Baseline, Month 3 |
|
Adverse events were collection for the duration of the study (2 years).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
A small number of participants was analyzed due to limited enrollment and completion rates.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claude Jarrett, M.D. | Emory University | 404-778-8099 | CJarrett@wilmingtonhealth.com |
Not provided
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D000092503 | Wrist Fractures |
| D011885 | Radius Fractures |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D005543 | Forearm Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
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. |
| Baseline, Month 3 |
Participants were randomized to receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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. | Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 6, Week 12 |
|
|
|
| Primary | Change in Grip Strength | Grip strength will be assessed by bilateral dynamometer testing. | Data for this outcome measure are not available for analysis. | Posted | Baseline, Month 3 |
|
|
| Primary | Complication Rate | The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction. | Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits. | Posted | Count of Participants | Participants | Duration of Study (Up to 3 Months) |
|
|
|
| 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. | Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 6, Week 12 |
|
|
|
| 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. | Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 6, Week 12 |
|
|
|
| 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. | No participants completed this survey as this outcome measure was removed from the protocol. No data were collected. | Posted | Baseline, Month 3 |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Week 12 |
|
| Title | Measurements |
|---|---|
|
| Week 12 |
|
| Title | Measurements |
|---|---|
|
| Week 12 |
|