Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures

• ClinicalTrials.gov Identifier: NCT02345369
• Recruitment Status: Terminated
• First Posted: January 26, 2015
• Results First Posted: August 2, 2018
• Last Update Posted: August 2, 2018
• Sponsor: Bassett Healthcare
• Information provided by (Responsible Party): Jennifer Victory, RN, CCRC, Bassett Healthcare

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hip Fractures	Device: Locked Set Screw; Device: Unlocked Set Screw	Not Applicable

Detailed Description:

Intramedullary hip screw devices can be inserted with and without locking of the set screw, with the purpose of the set screw to minimize shortening of the femoral neck by rigidly positioning the head screw that inserts into the femoral head. Rigid locking of the lag screw may also limit the ability of the fracture fragments to compress against each other gradually with weight bearing and this potentially could reduce healing at the fracture site. Alternatively, more settling at the fracture site may allow more reliable healing while allowing more shortening of the femoral neck at the fracture site. Shortening of the femoral neck fracture can result in gait disturbances and poor hip function, while delay in healing can contribute to hardware failure and need for revision surgery. The benefit of placing the set screw in intramedullary hip screw fixation has not been clearly established in the literature. To date, there has been no study addressing this question, and the decision to lock, or not lock the screw is based on individual surgeon discretion. This study will help to clarify this decision point in the treatment of intertrochanteric hip fractures with the Intertan (Smith and Nephew, Memphis, Tn) intramedullary nail. This will lead to better patient outcomes, and help clarify the standard of care in these very common fracture patterns.

Subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will be randomized to undergo fixation with an intramedullary hip screw with and without locking of the set screw. These subjects will be blinded to the study group and will be treated as per standard of care after fixation of a hip fracture with xrays immediately after surgery, at 1-2 weeks, 6 weeks, and then 3 and 6 months post operatively. As per standard care additional xrays would be indicated until union of the fracture if there is delayed healing. 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 from the xray images. TraumaCad software (Voyanthealth, Westchester, Il) will be utilized to obtain standardized measurements. A blinded subinvestigator will review the participants' x-rays and make the measurements required to determine the study outcomes. Time to radiographic union and any occurrence of hardware failure, nonunion and malunion will be noted. Demographic data including age, gender, smoking history, and medical comorbidities will be collected based on chart review. Subjective outcome scores (modified Harris hip score) will be collected at 3 and 6 months after surgery.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does Static Locking of Set Screws in Intramedullary Fixation of Intertrochanteric Fractures Prevent Shortening of Intertrochanteric Hip Fractures?
• Study Start Date: January 2015
• Actual Primary Completion Date: May 24, 2016
• Actual Study Completion Date: May 24, 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Device: Locked Set Screw; Fixation of hip fracture with intramedullary hip screw with locking of the set screw
Active Comparator: 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.	Device: Unlocked Set Screw; Fixation of hip fracture with intramedullary hip screw without locking of the set screw

Outcome Measures

Primary Outcome Measures :

1. Femoral Neck Shortening [ Time Frame: 6 months ]
   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.

Secondary Outcome Measures :

1. Time to Radiographic Union [ Time Frame: 6 months ]
   Time to radiographic union and any occurrence of hardware failure, nonunion and malunion will be noted
2. Harris Hip Score [ Time Frame: 6 months ]
   Subjective outcome scores (modified Harris hip score) will be collected at 3 and 6 months after surgery.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, New York

Bassett Healthcare Network

Cooperstown, New York, United States, 13326

Sponsors and Collaborators

Bassett Healthcare

Investigators

• Principal Investigator: jocelyn wittstein, MD; Bassett Healthcare

More Information

• Responsible Party: Jennifer Victory, RN, CCRC, Clinical Research Nurse Supervisor, Bassett Healthcare
• ClinicalTrials.gov Identifier: NCT02345369
• Other Study ID Numbers: 1095
• First Posted: January 26, 2015
• Results First Posted: August 2, 2018
• Last Update Posted: August 2, 2018
• Last Verified: July 2018

Additional relevant MeSH terms:

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