Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures

NCT02345369 | Terminated Results

• 1 other identifier: 1095
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at the effect of locking or not locking a set screw when placing a rod and screws device in the thigh bone and hip to fix hip fractures. The set screw is an extra screw in the device that will not allow the screw that goes into the ball of the ball and socket joint in the hip to slide at all in relation to the rod in the thigh bone, which it goes through. It is not known whether it is better to lock the set screw (not allow sliding of the hip screw) or leave it unlocked (allow sliding of the hip screw). Participants in this study are patients with intertrochanteric hip fractures receiving standard care for this injury (lining the fracture up in a normal position and inserting a rod in the thigh bone with a screw that goes through the rod into the ball of the ball and socket of the hip). Patients who consent to participate will be randomized to one of two arms : 1. Set screw is unlocked or 2. Set screw is locked. Participants will all get standard postoperative care and standard postoperative xrays.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Femoral Neck Shortening

  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.

  6 months

Secondary Outcomes (2)

• Time to Radiographic Union

  6 months

• Harris Hip Score

  6 months

Study Arms (2)

Locked Set Screw

ACTIVE COMPARATOR

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.

Device: Locked Set Screw

Unlocked Set Screw

ACTIVE COMPARATOR

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.

Device: Unlocked Set Screw

Interventions

Locked Set Screw DEVICE

Fixation of hip fracture with intramedullary hip screw with locking of the set screw

Locked Set Screw

Unlocked Set Screw DEVICE

Fixation of hip fracture with intramedullary hip screw without locking of the set screw

Unlocked Set Screw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects 18 years or older who are:
• mentally competent to give consent and complete the follow up questionnaires
• being treated for an intertrochanteric hip fracture,
• classified as Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association (AO/OTA) 31-A2 or A3
• plan to be treated with an intramedullary hip screw

You may not qualify if:

• infection in the involved joint or surrounding soft tissues,
• pathological fractures as a result of metastatic or primary bone tumors, progressive or debilitating neurological conditions resulting in significant movement or gait disorders, congenital bone disorders or heritable bone disorders (excluding osteoporosis and osteopenia),
• severe dementia,
• nonambulatory patients.

Sponsors & Collaborators

• Bassett Healthcare: lead

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Results Point of Contact

• Title: clinical research nurse supervisor
• Organization: Bassett Medical Center

jennifer.victory@bassett.org

6075476965

Study Officials

• jocelyn wittstein, MD

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Nurse Supervisor

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 26, 2015
• Study Start: January 1, 2015
• Primary Completion: May 24, 2016
• Study Completion: May 24, 2016
• Last Updated: August 2, 2018
• Results First Posted: August 2, 2018

Record last verified: 2018-07

Locations

US (1)