Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace

This study has been completed.
Sponsor:
Collaborator:
AirCast LLC
Information provided by (Responsible Party):
David Dennison, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587795
First received: December 21, 2007
Last updated: October 23, 2012
Last verified: April 2012
  Purpose

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.

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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587795

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
AirCast LLC
Investigators
Principal Investigator: David G Dennison, MD Mayo Clinic
  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 April 14, 2014