Trial Outcomes & Findings for Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures (NCT NCT02345369)

Results Overview

Femoral neck shortening will be measured radiographically with femoral neck offset and the femoral neck shaft angle to be measured radiographically based on standardized computerized measurements based off of PACs images. TraumaCad software (Voyanthealth, Westchester, Il) will be utilized to obtain standardized measurements.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

6 months

Results posted on

2018-08-02

Participant Flow

recruitment ended when lead surgeon left the institution \& types of implants used by institution were changed

Participant milestones

Participant milestones
Measure	Locked Set Screw In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw with locking of the set screw. Locked Set Screw: Fixation of hip fracture with intramedullary hip screw with locking of the set screw	Unlocked Set Screw In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw without locking of the set screw. Unlocked Set Screw: Fixation of hip fracture with intramedullary hip screw without locking of the set screw
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

Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 6 months

Population: no outcomes to report

Femoral neck shortening will be measured radiographically with femoral neck offset and the femoral neck shaft angle to be measured radiographically based on standardized computerized measurements based off of PACs images. TraumaCad software (Voyanthealth, Westchester, Il) will be utilized to obtain standardized measurements.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: no outcomes to report

Time to radiographic union and any occurrence of hardware failure, nonunion and malunion will be noted

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: no outcomes to report

Subjective outcome scores (modified Harris hip score) will be collected at 3 and 6 months after surgery.

Outcome measures

Outcome data not reported

Adverse Events

Locked Set Screw

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unlocked Set Screw

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

clinical research nurse supervisor

Bassett Medical Center

Phone: 6075476965

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place