- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02345369
Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures
Does Static Locking of Set Screws in Intramedullary Fixation of Intertrochanteric Fractures Prevent Shortening of Intertrochanteric Hip Fractures?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Cooperstown, New York, United States, 13326
- Bassett Healthcare Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
Fixation of hip fracture with intramedullary hip screw without locking of the set screw
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Radiographic Union
Time Frame: 6 months
|
Time to radiographic union and any occurrence of hardware failure, nonunion and malunion will be noted
|
6 months
|
Harris Hip Score
Time Frame: 6 months
|
Subjective outcome scores (modified Harris hip score) will be collected at 3 and 6 months after surgery.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: jocelyn wittstein, MD, Bassett Healthcare
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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