Radius; Fracture, Lower or Distal EndNCT02066857
Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly
A study testing Cast made of generic plaster or fiberglass cast material and Generic "off the shelf" removable splint in people with Radius; Fracture, Lower or Distal End, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Radius; Fracture, Lower or Distal End
- What is being tested?
- Cast made of generic plaster or fiberglass cast material and Generic "off the shelf" removable splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329
About this study
Official title: Use of Cast Versus Removable Splints for Minimally Displaced Distal Radius Fractures in Elderly Patients: A Prospective, Randomized Trial
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
- Being tested
- Cast made of generic plaster or fiberglass cast material, Generic "off the shelf" removable splint
- Keywords
- Wrist fracture, Radius fracture, Elderly, Splint, Cast
- Medical subject headings
- Fractures, Bone, Wrist Fractures, Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast made of generic plaster or fiberglass cast materialDevice
Also called No brand name applicable.
Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture.
Generic "off the shelf" removable splintDevice
Also called No brand name applicable
Patients will be randomized to receive a generic "off the shelf" removable splint for treatment of a non-displaced distal radius fracture.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Generic "off the shelf" removable splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wrist Range of Motion (ROM)
Wrist ROM will be assessed by a goniometer exam.
Measured: 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.
Measured: Baseline, Week 2, Week 6, Week 12
Change in Grip Strength
Grip strength will be assessed by bilateral dynamometer testing.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, Week 6, Week 12
Secondary outcomes (2)
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.
Measured: Baseline, Week 2, Week 6, Week 12
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.
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Radius; Fracture, Lower or Distal EndStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudius Jarrett, Emory University
- Investigators
- Claudius Jarrett, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066857
- Sponsor's protocol ID
- IRB00071060
- Status last verified
- May 2017
- First submitted
- 14 Feb 2014
- Last updated
- 24 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cast Versus Removable Splints for Minimally Displaced Distal Radius Fractures in Elderly Patients: A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT02066857
- Acronym / sponsor ID
- IRB00071060
- Conditions
- Radius; Fracture, Lower or Distal End
- Keywords
- Wrist fracture, Radius fracture, Elderly, Splint, Cast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Posted 24 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic plaster or fiberglass cast group | Active comparator | Device: Cast made of generic plaster or fiberglass cast materialPatients 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 | Device: Generic "off the shelf" removable splintSubjects will be randomized and receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cast made of generic plaster or fiberglass cast materialAlso: No brand name applicable.Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture. | Device | Generic plaster or fiberglass cast group |
| Generic "off the shelf" removable splintAlso: No brand name applicablePatients will be randomized to receive a generic "off the shelf" removable splint for treatment of a non-displaced distal radius fracture. | Device | Generic "off the shelf" removable splint group |
Primary outcome
Change in Wrist Range of Motion (ROM)
Time frame: Baseline, Month 3
Wrist ROM will be assessed by a goniometer exam.
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.
Change in Grip Strength
Time frame: Baseline, Month 3
Grip strength will be assessed by bilateral dynamometer testing.
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.
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.
2 secondary outcomes
Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score
Time frame: Baseline, Week 2, Week 6, Week 12
Change in SF-12 QOL
Time frame: Baseline, Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Radius; Fracture, Lower or Distal End
Not yet recruiting
Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures
Distal Radius Fracture, Radius Fracture Distal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudius Jarrett, M.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cast made of generic plaster or fiberglass cast material and Generic "off the shelf" removable splint in people with Radius; Fracture, Lower or Distal End, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wrist Range of Motion (ROM) (time frame: Baseline, Month 3). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.