NCT00587795

Brief Summary

Objectives: \- To obtain clinical evidence for the safety and efficacy in using the StabilAir Wrist Fracture Brace for the following cases:

  1. 1.Acute (emergency department) treatment of non-displaced, stable extra- articular distal radius fractures;
  2. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

August 2, 2017

Completed
Last Updated

August 2, 2017

Status Verified

April 1, 2017

Enrollment Period

2.3 years

First QC Date

December 21, 2007

Results QC Date

April 25, 2017

Last Update Submit

April 25, 2017

Conditions

Radius Fractures

Outcome Measures

Primary Outcomes (1)

  • 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).

    baseline, 8 weeks

Study Arms (2)

StabilAir Wrist Brace

ACTIVE COMPARATOR

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

Device: StabilAir Wrist Brace

Control

PLACEBO COMPARATOR

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

Interventions

StabilAir Wrist BraceDEVICE

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.

StabilAir Wrist Brace
Placement of sugar tong splint or plaster castOTHER

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.

Also known as: Sugar tong splint or plaster cast
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and Females Age ≥ 18 yrs
  • Undisplaced distal radial fractures (with/without ulnar styloid fractures)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Radius Fractures

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Limitations and 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.

Results Point of Contact

Title
Dr. David Dennison
Organization
Mayo Clinic
Dennison.David@mayo.edu
507-284-7405

Study Officials

  • David G Dennison, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

April 1, 2006

Primary Completion

August 1, 2008

Study Completion

November 1, 2008

Last Updated

August 2, 2017

Results First Posted

August 2, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)