Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace

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.

Study Overview

• Status: Terminated
• Conditions: Radius Fractures
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Sugar tong splint or plaster cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Distal Radius Fracture at 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).	baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: AirCast LLC
• Investigators: Principal Investigator: David G Dennison, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 7, 2008

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: 228-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No