Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
Stopped early · Not applicable
Conditions studied: Radius Fractures
In brief
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. 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: 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.
Key facts
- Study ID
- NCT00587795
- Run by
- Mayo Clinic
- People needed
- 1
- Starts
- 2006-04-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2017-08-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and Females Age ≥ 18 yrs
- Undisplaced distal radial fractures (with/without ulnar styloid fractures)
You may not qualify if…
- 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)
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.