Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
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Purpose
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.
This will provide a complete cost-of-care analysis from one modality to the other.
Hypothesis:
1) 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.
The benefit of utilizing a product of this type in the acute or follow-up setting is that it is an adjustable fit, "off-the-shelf" device, which can be quickly and comfortably applied to the patient. It can then transition effectively to be the product of choice for the remainder of treatment through rehabilitation since it will protect, stabilize, and support the injury while adapting to changing patient conditions and needs. Because it is removable (late but not early in fracture core period) there are potential benefits to comfort and hygiene. Therefore, the total cost of care is reduced by using one product from the progress of the injury to fracture reduction and through to recovery (rather than a variety of products that require investment in materials, time, and personnel for cast changes and potential fracture re-reduction. In the initial treatment period, the StabilAir Brace will be firmly held in place by a peripheral "guard wrap" and will only be removed under the supervision of the treating surgeon. Only when clear evidence of fracture healing is present would the patient be allowed to physically remove the brace.
| Condition | Intervention |
|---|---|
|
Radius Fractures |
Device: StabilAir Wrist Brace Other: Placement of sugar tong splint or plaster cast |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace |
- 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; [ Time Frame: 6 weeks; 3, 12 and 24 months ] [ Designated as safety issue: No ]
- To obtain comparative data between traditional therapies and the use of the StabilAir brace for each patient qualified by specific criteria. This will provide a complete cost-of-care analysis from one modality to the other. [ Time Frame: 6 weeks; 3, 12 and 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | April 2006 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Active Comparator
One study group will consist of patients treated with the StabilAir brace
|
Device: StabilAir Wrist Brace
Patient will be placed in a StabilAir Wrist Brace 10-14 days after iniital injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months. X-rays and an exam will be obtained at each visit. In addition, patients will be asked to complete the Disability of the Arm, Shoulder and Hand (DASH) and Patient Rated Wrist Evaluation (PRWE) questionniares regarding their general health, daily activities and pain.
Other Name: StabilAir Wrist Brace
|
|
Placebo Comparator: Control
Study arm will consist of patients that are treated with either sugar tong splint or plaster casting
|
Other: Placement of sugar tong splint or plaster cast
Patients will recevie 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 Name: Sugar tong splint or plaster cast
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and Females Age ≥ 18 yrs
- Undisplaced distal radial fractures (with/without ulnar styloid fractures)
Exclusion Criteria:
- Age < 18 yrs
- Intra-articular fracture - displaced
- Loss of reduction after cast or brace treatment
- Excessive comminution (> 50% metophysis)
- Failed closed reduction (Unacceptable alignment s/p CR: Short >2mm; Dorsal angulation >0° (neutral), Radial inclination < 15°)
- Ipsilateral ulna fractures (not styloid)
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | David Dennison, PI, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00587795 History of Changes |
| Other Study ID Numbers: | 228-06, StabilAir Wrist Orthosis |
| Study First Received: | December 21, 2007 |
| Last Updated: | October 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fractures, Bone Radius Fractures Wounds and Injuries Forearm Injuries Arm Injuries |
ClinicalTrials.gov processed this record on May 22, 2013