We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00587795
Recruitment Status : Terminated (Inability to enroll subjects)
First Posted : January 7, 2008
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.


Condition or disease Intervention/treatment
Radius Fractures Device: StabilAir Wrist Brace Other: Placement of sugar tong splint or plaster cast

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
Study Start Date : April 2006
Primary Completion Date : August 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 (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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: David Dennison, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587795     History of Changes
Other Study ID Numbers: 228-06
First Posted: January 7, 2008    Key Record Dates
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries