Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/4/2018 |
| Start Date: | January 2015 |
| End Date: | May 24, 2016 |
Does Static Locking of Set Screws in Intramedullary Fixation of Intertrochanteric Fractures Prevent Shortening of Intertrochanteric Hip Fractures?
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.
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.
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.
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.
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.
We found this trial at
1
site
Cooperstown, New York 13326
Principal Investigator: jocelyn Wittstein, MD
Phone: 607-547-6965
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