Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 7:48 AM
Study NCT ID:
NCT00587795
Status:
TERMINATED
Last Update Posted:
2017-08-02
First Post:
2007-12-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to enroll subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: