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Trial Outcomes & Findings for Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment (NCT NCT01975467)

NCT ID: NCT01975467

Last Updated: 2016-12-28

Results Overview

Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.

Recruitment status

TERMINATED

Target enrollment

9 participants

Primary outcome timeframe

One time point

Results posted on

2016-12-28

Participant Flow

Participant milestones

Participant milestones
Measure
Control Group - Nonoperative
Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
Test Group - Intramedullary Nail
Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture. CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.
Overall Study
STARTED
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post Treatment Comparison Intramedullary Nail vs. Nonoperative Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group - Nonoperative
Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
Test Group - Intramedullary Nail
Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture. CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.
Total
Total of all reporting groups
Gender
Female
—
—
0
n=5 Participants
Gender
Male
—
—
0
n=5 Participants

PRIMARY outcome

Timeframe: One time point

Population: Terminated due to low enrollment

Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One time point

The ASES instrument will be used to assess range of motion and strength.

Outcome measures

Outcome data not reported

Adverse Events

Control Group - Nonoperative

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Test Group - Intramedullary Nail

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

Rick Epstein

Sonoma Orthopedics

Phone: 8479872516

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place