Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
Primary Purpose
Radius Fractures
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
StabilAir Wrist Brace
Placement of sugar tong splint or plaster cast
Sponsored by
About this trial
This is an interventional treatment trial for Radius Fractures
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
StabilAir Wrist Brace
Control
Arm Description
One study group will consist of patients treated with the StabilAir Wrist Brace.
Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00587795
First Posted
December 21, 2007
Last Updated
April 25, 2017
Sponsor
Mayo Clinic
Collaborators
AirCast LLC
1. Study Identification
Unique Protocol Identification Number
NCT00587795
Brief Title
Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
Official Title
Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Inability to enroll subjects
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
AirCast LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
Acute (emergency department) treatment of non-displaced, stable extra- articular distal radius fractures;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
StabilAir Wrist Brace
Arm Type
Active Comparator
Arm Description
One study group will consist of patients treated with the StabilAir Wrist Brace.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.
Intervention Type
Device
Intervention Name(s)
StabilAir Wrist Brace
Intervention Description
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
Other
Intervention Name(s)
Placement of sugar tong splint or plaster cast
Other Intervention Name(s)
Sugar tong splint or plaster cast
Intervention Description
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.
Primary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Dennison, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
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