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:
- 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.
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.
|Radius Fractures||Device: StabilAir Wrist Brace Other: Placement of sugar tong splint or plaster cast|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace|
- 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).
|Study Start Date:||April 2006|
|Study Completion Date:||November 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Active Comparator: StabilAir Wrist Brace
One study group will consist of patients treated with the StabilAir Wrist Brace.
Device: StabilAir Wrist Brace
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.
Placebo Comparator: Control
Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.
Other: Placement of 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.
Other Name: Sugar tong splint or plaster cast
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587795
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||David G Dennison, MD||Mayo Clinic|