Trial Outcomes & Findings for Short Forearm Casting Versus Below-elbow Splinting for Acute Immobilization of Distal Radius Fractures (NCT NCT02679066)

Results Overview

Radiologic parameters to include radial height, radial inclination and volar tilt will be measured from post-immobilization radiographs at presentation, one week, two weeks and four weeks. Maintenance of reduction will be defined as: loss of reduction of \< 2 mm radial height, \< 5 degrees of radial inclination or \< 10 degrees of volar tilt and/or \< 2 mm intra-articular step off, in follow up radiographs as compared to immediate post-reduction radiographs.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

one month

Results posted on

2020-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Sugar-tong Splint Patients are placed in a sugar-tong splint for immobilization of the distal radius fracture. Sugar-tong splint: Plaster immobilization including the elbow	Short Forearm Cast Patients are placed in a short forearm cast, with bivalve, for immobilization of the distal radius fracture. Short forearm cast: Fiberglass immobilization with elbow free
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Short Forearm Casting Versus Below-elbow Splinting for Acute Immobilization of Distal Radius Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar-tong Splint n=100 Participants Patients are placed in a sugar-tong splint for immobilization of the distal radius fracture. Sugar-tong splint: Plaster immobilization including the elbow	Short Forearm Cast n=100 Participants Patients are placed in a short forearm cast, with bivalve, for immobilization of the distal radius fracture. Short forearm cast: Fiberglass immobilization with elbow free	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=113 Participants	60 Participants n=163 Participants	125 Participants n=160 Participants
Age, Categorical >=65 years	35 Participants n=113 Participants	40 Participants n=163 Participants	75 Participants n=160 Participants
Sex: Female, Male Female	NA Participants n=113 Participants	NA Participants n=163 Participants	NA Participants n=160 Participants
Sex: Female, Male Male	NA Participants n=113 Participants	NA Participants n=163 Participants	NA Participants n=160 Participants
Race/Ethnicity, Customized	NA Participants n=113 Participants	NA Participants n=163 Participants	NA Participants n=160 Participants

PRIMARY outcome

Timeframe: one month

Population: No data was collected to allow analysis.

Radiologic parameters to include radial height, radial inclination and volar tilt will be measured from post-immobilization radiographs at presentation, one week, two weeks and four weeks. Maintenance of reduction will be defined as: loss of reduction of \< 2 mm radial height, \< 5 degrees of radial inclination or \< 10 degrees of volar tilt and/or \< 2 mm intra-articular step off, in follow up radiographs as compared to immediate post-reduction radiographs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Two weeks

Population: No data was measured due to inconsistent collection of DASH score and patient follow up.

This is a validated survey of upper extremity function that is administered at the two week follow up visit. The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability).

Outcome measures

Outcome data not reported

Adverse Events

Sugar-tong Splint

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Short Forearm Cast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Erik Hasenboehler MD

Johns Hopkins Bayview

Phone: 4105504190

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place