Hip FracturesNCT02345369
Locked Versus Unlocked Set Screws in Intramedullary Fixation of Intertrochanteric Fractures
A study testing Locked Set Screw and Unlocked Set Screw in people with Hip Fractures, run by Bassett Healthcare at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Locked Set Screw and Unlocked Set Screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 24 May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bassett Healthcare Network
Cooperstown, New York, 13326
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- Locked Set Screw, Unlocked Set Screw
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locked Set ScrewDevice
Fixation of hip fracture with intramedullary hip screw with locking of the set screw
Unlocked Set ScrewDevice
Fixation of hip fracture with intramedullary hip screw without locking of the set screw
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Unlocked Set Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Time to Radiographic Union
Time to radiographic union and any occurrence of hardware failure, nonunion and malunion will be noted
Measured: 6 months
Harris Hip Score
Subjective outcome scores (modified Harris hip score) will be collected at 3 and 6 months after surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion24 May 2016
- Study completion24 May 2016
Why it stopped: change in surgical implant use, loss of subinvestigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bassett Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Victory, RN, CCRC, Bassett Healthcare
- Investigators
- jocelyn wittstein, MD, Principal investigator, Bassett Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345369
- Sponsor's protocol ID
- 1095
- Status last verified
- Jul 2018
- First submitted
- 20 Jan 2015
- Last updated
- 2 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Static Locking of Set Screws in Intramedullary Fixation of Intertrochanteric Fractures Prevent Shortening of Intertrochanteric Hip Fractures?
- ClinicalTrials.gov ID
- NCT02345369
- Acronym / sponsor ID
- 1095
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in surgical implant use, loss of subinvestigator
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bassett HealthcareUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 24 May 2016 (actual)
- Study completion
- 24 May 2016 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Posted 2 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locked Set Screw | Active comparator | Device: Locked Set ScrewIn 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. |
| Unlocked Set Screw | Active comparator | Device: Unlocked Set ScrewIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locked Set ScrewFixation of hip fracture with intramedullary hip screw with locking of the set screw | Device | Locked Set Screw |
| Unlocked Set ScrewFixation of hip fracture with intramedullary hip screw without locking of the set screw | Device | Unlocked Set Screw |
Primary outcome
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.
2 secondary outcomes
Time to Radiographic Union
Time frame: 6 months
Harris Hip Score
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jocelyn wittstein, MD principal investigator
Bassett Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locked Set Screw and Unlocked Set Screw in people with Hip Fractures, run by Bassett Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral Neck Shortening (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.