Trial Outcomes & Findings for Progressive Splinting Status Post Elbow Fractures and Dislocations (NCT NCT00580866)

Results Overview

The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively

Results posted on

2016-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	Brace Group JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.	PT Only Group
Overall Study STARTED	10	7
Overall Study COMPLETED	8	5
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Brace Group JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.	PT Only Group
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Progressive Splinting Status Post Elbow Fractures and Dislocations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brace Group n=10 Participants JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.	PT Only Group n=7 Participants	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks, 6 weeks, 3 months, 6 months, 12 months post-operatively

Population: Elbow ROM at 12 months analysis. Data was not collected at 2 weeks, 6 weeks, 3 months, 6 months due to poor enrollment.

The goal of this study is to determine if static progressive splinting eliminates deformity by improving patients' range of motion.

Outcome measures

Outcome measures
Measure	Brace Group n=8 Participants JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.	PT Only Group n=5 Participants
Elbow ROM at 12 Months	121 degrees Interval 110.0 to 130.0	123 degrees Interval 119.0 to 129.0

SECONDARY outcome

Timeframe: 12 months post-operatively

Improvement of patient's overall functional outcome will be measured by a standard functional outcome instrument, the DASH Score. The results can range from 0 (no disability) to 100 (worst )

Outcome measures

Outcome measures
Measure	Brace Group n=8 Participants JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.	PT Only Group n=5 Participants
Disabilities of the Arm, Shoulder and Hand (DASH) Score	25 scores on a scale Interval 21.0 to 29.0	23 scores on a scale Interval 19.0 to 27.0

Adverse Events

Brace Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PT Only Group

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

William Obremskey

Vanderbilt

Phone: 6159363630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place