Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace

• Sponsor: Mayo Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00587795
• Collaborator: AirCast LLC (Industry)
• Enrollment: 1
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 0

Study Details

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	Phase
Radius Fractures	Device: StabilAir Wrist Brace; Other: Placement of sugar tong splint or plaster cast	N/A

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
• 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: Apr 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Nov 1, 2008

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 Names: Sugar tong splint or plaster cast

Outcome Measures

Primary Outcome Measures

1. Change in Distal Radius Fracture at 8 Weeks [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• AirCast LLC

Investigators

• Principal Investigator: David G Dennison, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Dennison, PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00587795
• Other Study ID Numbers: 228-06
• First Posted: Jan 7, 2008
• Last Update Posted: Aug 2, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

Participant Flow

Recruitment Details	One subject was recruited from the Mayo Clinic in Rochester, Minnesota in 2007.

Arm/Group Title	StabilAir Wrist Brace	Control
Arm/Group Description	One study group will consist of patients treated with the StabilAir Wrist Brace. 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.	Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast. 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.
Period Title: Overall Study
STARTED	1	0
COMPLETED	0	0
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	StabilAir Wrist Brace	Control	Total
Arm/Group Description	One study group will consist of patients treated with the StabilAir Wrist Brace. 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.	Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast. 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.	Total of all reporting groups
Overall Participants	1	0	1
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%
Between 18 and 65 years	0 0%	0 NaN	0 0%
>=65 years	1 100%	0 NaN	1 100%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 NaN
Male	1 100%	1 Infinity
Region of Enrollment (participants) [Number]
United States	1 100%	1 Infinity

Outcome Measures

1. Primary Outcome

Title	Change in Distal Radius Fracture at 8 Weeks
Description	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).
Time Frame	baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	StabilAir Wrist Brace	Control
Arm/Group Description	One study group will consist of patients treated with the StabilAir Wrist Brace. 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.	Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast. 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.
Measure Participants	0	0

Adverse Events

Arm/Group Title	StabilAir Wrist Brace		Control
Arm/Group Description	One study group will consist of patients treated with the StabilAir Wrist Brace. 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.		Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast. 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.
All Cause Mortality
	StabilAir Wrist Brace		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Serious Adverse Events
	StabilAir Wrist Brace		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	StabilAir Wrist Brace		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)

Limitations/Caveats

Early termination due to inability to enroll subjects, and concern about subject compliance in the use of the Stabilair wrist brace. The one subject enrolled disliked the brace and quickly withdrew from the study.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.