Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace

NCT ID: NCT00587795

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-11-30

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.

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.

Conditions

Radius Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

StabilAir Wrist Brace

One study group will consist of patients treated with the StabilAir Wrist Brace.

Group Type: ACTIVE_COMPARATOR

StabilAir Wrist Brace

Intervention Type: DEVICE

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.

Control

Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.

Group Type: PLACEBO_COMPARATOR

Placement of sugar tong splint or plaster cast

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Sugar tong splint or plaster cast

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AirCast LLC

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

David Dennison

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David G Dennison, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

228-06

Identifier Type: -

Identifier Source: org_study_id