Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace

Radius Fractures Clinical Trial

Official title:

Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587795
• Other study ID #: 228-06
• Secondary ID: StabilAir Wrist
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: October 23, 2012
• Start date: April 2006
• Est. completion date: November 2008

Study information

• Verified date: April 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Description:

Data Collection and Study Design:

This will be a single center, prospective, randomized controlled trial. We will collect data from 80 patients with undisplaced distal radius fractures. Half will be treated with the plastic back slab or sugar tong splint (if there is ulnar styloid fracture) and half will be treated with the StabilAir splint. The initial treatment, which occurs upon the patient's arrival at the emergency room and prior to study randomization, will require full forearm and wrist immobilization in the acute phase treated with sugar tong splinting. At the patient's follow-up visit, which will happen ≤10 days post injury and initial evaluation, when it is determined that full forearm immobilization is no longer necessary, patients will be 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 will be controlled by the study coordinator. One study group will consist of patients that are treated with either sugar tong splint or plaster casting and the other study group will consist of patients treated with the StabilAir brace. Throughout entire study, the sugar tong splint/casting patients will be the control group.

Patients will be asked to return for the following visits after they are 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 will have x-rays of their wrist and an exam with the physician. In addition, they will be asked to complete the DASH and PRWE questionnaires regarding their general health, daily activities and pain.

The decision for treatment will be made using the LaFontaine criteria. If there is a combination of 3 or less LaFontaine criteria (displacement, comminution, distal radio-ulnar joint injury, age >60 years), and no intra-articular involvement, then the patient fits criteria for inclusion. Exclusion criteria include intra-articular fractures, excessive comminution, open fractures, and failed closed reduction of the fracture requiring open reduction. Patients with loss of reduction requiring secondary treatment will be excluded.

Assessment of Results:

The results of treatment will be assessed by clinical, radiographic and patient assessment criteria. Clinical objective assessment will be performed by the Gartland-Werley score and Mayo Wrist Score. Radiographic assessments were made by the Stewart Score and measures of dorsal angulation, radial shortening, radio-ulnar test. Functional scores will include the DASH (disabilities arm, shoulder, hand) and PRWE (patient related wrist evaluation).

Acute Care (ED) Nondisplaced and/or No Forearm Immobilization Required

Outcome Measurements:

• Initial displacement vs position of distal fragment at 8 weeks (Bunger et al. method)

• End fragment position of StabilAir brace patients vs traditionally treated patients

• Statistical comparison with paired T-test. We will be comparing radiographic parameters (intrarticular or displaced, Dorsal angulation , Shortening, radial inclination), and outcome scores from the DASH and PRWE to identify any significant differences based upon an n = 40. We predict assuming a two-sample t-test is used to compare the two arms, you will have 80% power to detect an effect size of 0.90 (almost 1 SD).

Materials:

• StabilAir Wrist fracture orthoses

• Stockinets (extra supply for subsequent application to patient)

• Hand-bulb and pressure gauge

• Patient data collection forms - initial and follow-up

• Cast and sugar tong materials

• Patient surveys

Patient Inclusion Criteria:

• Males and Females Age ≥ 18 yrs

• Undisplaced distal radial fractures (with/without ulnar styloid fractures)

Patient 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 Results

Tabular format to show:

1. Anatomical scores (radiographic scores - Stewart)

2. Functional scores (DASH, PRWE)

3. Objective motion and grip strength

4. Wrist scores (Mayo or Krimmer wrist score)

5. Summarize statistical trends.

Discussion:

Do the results agree with or support the hypothesis? Is there a clear difference between treatment types? Is there potential for loss of reduction quotes with use of an aircast brace? Is there a greater number of patients converted over from standard cast or sugar tong splint treatment to ORIF vs external fixation (assuming similar fracture stability criteria) in compression to the Aircast Stabilair Brace? Positive feedback indicating benefits to patient's clinical outcome and level of comfort and hand functional use comparing cast treatment vs bracing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fractures

Intervention

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:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	AirCast LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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;		6 weeks; 3, 12 and 24 months	No
Secondary	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.		6 weeks; 3, 12 and 24 months	No