Radius FracturesNCT00587795
Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
A study testing StabilAir Wrist Brace and Placement of sugar tong splint or plaster cast in people with Radius Fractures, run by Mayo Clinic at 1 site in United States.
Trial summary
Objectives: To obtain clinical evidence for the safety and efficacy in using the StabilAir Wrist Fracture Brace for the following cases: 1. Acute (emergency department) treatment of non-displaced, stable extra- articular distal radius fractures; 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Fractures
- What is being tested?
- StabilAir Wrist Brace and Placement of sugar tong splint or plaster cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Nov 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females Age ≥ 18 yrs
- Undisplaced distal radial fractures (with/without ulnar styloid fractures)
Who cannot join
- Age < 18 yrs
- Intra-articular fracture - displaced
- Loss of reduction after cast or brace treatment
- Excessive comminution (> 50% metophysis)
- Failed closed reduction (CR) (Unacceptable alignment status post CR: Short >2mm; Dorsal angulation >0° (neutral), Radial inclination < 15°)
- Ipsilateral ulna fractures (not styloid)
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- Open fracture
- Senile or dementia or lack of understanding of treatment
- Previous fracture distal radius
- Patients with displaced fractures that require pin fixation, external fixation, plate fixation or who qualify for "crystalline injection fracture healing protocol" are excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Objectives:
- To obtain clinical evidence for the safety and efficacy in using the StabilAir Wrist Fracture Brace for the following cases:
Read more
- Acute (emergency department) treatment of non-displaced, stable extra- articular distal radius fractures;
- To obtain comparative data between traditional therapies (sugar tong, plaster backslab, long arm or short arm cast) and the use of the StabilAir brace for each patient qualified by specific criteria.
Hypothesis:
- For stable, non-displaced fractures, the StabilAir Brace is as effective as a sugar tong splint in the acute setting. 2) In cases where full forearm immobilization is initially preferred, the StabilAir is effective as a follow-up to sugar tong splitting once the need for full immobilization has passed.
Read the detailed description
Data Collection and Study Design:
This will be a single center, prospective, randomized controlled trial. The investigators planned to collect data from 80 patients with undisplaced distal radius fractures. Half were to be treated with the plastic back slab or sugar tong splint (if there were an ulnar styloid fracture) and half were to be treated with the StabilAir splint. The initial treatment, which was to occur upon the patient's arrival at the emergency room and prior to study randomization, required full forearm and wrist immobilization in the acute phase treated with sugar tong splinting. At the patient's follow-up visit, which was to happen ≤10 days post injury and initial evaluation, when it was determined that full forearm immobilization was no longer necessary, patients were informed of the study, consented, and randomized (as in the flip of a coin) to one of the two study groups using a computerized randomization process that was controlled by the study coordinator. One study group was to consist of patients treated with either sugar tong splint or plaster casting and the other study group was to consist of patients treated with the StabilAir brace. Throughout entire study, the sugar tong splint/casting patients was to be the control group.
Patients were to be asked to return for the following visits after they were randomized:
- 10-14 days post randomization
- 35 to 42 days (5 to 6 weeks) post randomization
- 77 to 84 days (11 to 12 weeks) post randomization;
- And at 12 and 24 months.
At each visit they were to have x-rays of their wrist and an exam with the physician. In addition, they were to be asked to complete questionnaires regarding their general health, daily activities and pain.
- Conditions
- Radius Fractures
- Being tested
- StabilAir Wrist Brace, Placement of sugar tong splint or plaster cast
- Medical subject headings
- Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StabilAir Wrist BraceDevice
Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months.
Placement of sugar tong splint or plaster castOther
Also called Sugar tong splint or plaster cast
Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months.
| Study group | Role | What they receive |
|---|---|---|
| StabilAir Wrist Brace | Active comparator | One study group will consist of patients treated with the StabilAir Wrist Brace. Receives: Device: StabilAir Wrist Brace |
| Control | Placebo comparator | Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast. Receives: Other: Placement of sugar tong splint or plaster cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Distal Radius Fracture at 8 Weeks
The investigators planned to make radiographic assessments using the Stewart Score. The Stewart Score can range from 1 to 12, with a higher score indicating poor function: excellent (0), good (1-3), fair (4-6) and poor (7-12).
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startApr 2006
- Primary completionAug 2008
- Study completionNov 2008
Why it stopped: Inability to enroll subjects
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 FracturesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- AirCast LLC
- Responsible party
- Principal investigator, David Dennison, Mayo Clinic
- Investigators
- David G Dennison, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587795
- Sponsor's protocol ID
- 228-06
- Status last verified
- Apr 2017
- First submitted
- 21 Dec 2007
- Last updated
- 2 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
- ClinicalTrials.gov ID
- NCT00587795
- Acronym / sponsor ID
- 228-06
- Conditions
- Radius Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to enroll subjects
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- AirCast LLC
- Study start
- Apr 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- To obtain clinical evidence for the safety and efficacy in using the StabilAir Wrist Fracture Brace for the following cases:
- Acute (emergency department) treatment of non-displaced, stable extra- articular distal radius fractures;
- To obtain comparative data between traditional therapies (sugar tong, plaster backslab, long arm or short arm cast) and the use of the StabilAir brace for each patient qualified by specific criteria.
Hypothesis:
- For stable, non-displaced fractures, the StabilAir Brace is as effective as a sugar tong splint in the acute setting. 2) In cases where full forearm immobilization is initially preferred, the StabilAir is effective as a follow-up to sugar tong splitting once the need for full immobilization has passed.
Detailed description
Data Collection and Study Design:
This will be a single center, prospective, randomized controlled trial. The investigators planned to collect data from 80 patients with undisplaced distal radius fractures. Half were to be treated with the plastic back slab or sugar tong splint (if there were an ulnar styloid fracture) and half were to be treated with the StabilAir splint. The initial treatment, which was to occur upon the patient's arrival at the emergency room and prior to study randomization, required full forearm and wrist immobilization in the acute phase treated with sugar tong splinting. At the patient's follow-up visit, which was to happen ≤10 days post injury and initial evaluation, when it was determined that full forearm immobilization was no longer necessary, patients were informed of the study, consented, and randomized (as in the flip of a coin) to one of the two study groups using a computerized randomization process that was controlled by the study coordinator. One study group was to consist of patients treated with either sugar tong splint or plaster casting and the other study group was to consist of patients treated with the StabilAir brace. Throughout entire study, the sugar tong splint/casting patients was to be the control group.
Patients were to be asked to return for the following visits after they were randomized:
- 10-14 days post randomization
- 35 to 42 days (5 to 6 weeks) post randomization
- 77 to 84 days (11 to 12 weeks) post randomization;
- And at 12 and 24 months.
At each visit they were to have x-rays of their wrist and an exam with the physician. In addition, they were to be asked to complete questionnaires regarding their general health, daily activities and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StabilAir Wrist Brace | Active comparator | Device: StabilAir Wrist BraceOne study group will consist of patients treated with the StabilAir Wrist Brace. |
| Control | Placebo comparator | Other: Placement of sugar tong splint or plaster castStudy arm will consist of patients that are treated with placement of sugar tong splint or plaster cast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and Females Age ≥ 18 yrs
- Undisplaced distal radial fractures (with/without ulnar styloid fractures)
Key exclusion criteria (10 listed)
- Age < 18 yrs
- Intra-articular fracture - displaced
- Loss of reduction after cast or brace treatment
- Excessive comminution (> 50% metophysis)
- Failed closed reduction (CR) (Unacceptable alignment status post CR: Short >2mm; Dorsal angulation >0° (neutral), Radial inclination < 15°)
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 |
|---|---|---|
| StabilAir Wrist BracePatient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months. | Device | StabilAir Wrist Brace |
| Placement of sugar tong splint or plaster castAlso: Sugar tong splint or plaster castPatients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months. | Other | Control |
Primary outcome
Change in Distal Radius Fracture at 8 Weeks
Time frame: baseline, 8 weeks
The investigators planned to make radiographic assessments using the Stewart Score. The Stewart Score can range from 1 to 12, with a higher score indicating poor function: excellent (0), good (1-3), fair (4-6) and poor (7-12).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David G Dennison, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StabilAir Wrist Brace and Placement of sugar tong splint or plaster cast in people with Radius Fractures, run by Mayo Clinic 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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 2 Aug 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. Some participants in this study may receive a placebo. 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 2 Aug 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 Distal Radius Fracture at 8 Weeks (time frame: baseline, 8 weeks). 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 2 Aug 2017.