Hip FracturesNCT00664950
InterTAN IM Nail Versus Sliding Hip Screw in Geriatric Fractures
A study testing sliding hip screw and IntertAn IM nail in people with Hip Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
Trial summary
Elderly patients with an intertrochanteric hip fracture will be randomized to receive either a sliding hip screw (SHS) (control group) or InterTAN intermedullary nail (IMN) (experimental group) for surgical fixation of their hip fracture. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- sliding hip screw and IntertAn IM nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2007to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 years or greater*
- Intertrochanteric fracture amenable to treatment by sliding hip screw or intramedullary nail fixation
- Previously ambulatory (defined as not usually requiring a wheelchair for ambulation)*
- Provision of informed consent*
- Surgery performed within 72 hours of admission
Who cannot join
- Cognitive or language barriers that would limit completion of assessment tests in English*
- Anticipated problems with follow-up in the judgment of the resident, or attending surgeon (e.g of no fixed address)*
- Surgeon refusal to randomize patient
- Pathologic fractures
- Polytrauma that would impact functional assessments in the opinion of the surgeon
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
London Health Sciences Centre
London, Ontario, N6A 4G5
Ottawa Civic Hospital
Ottawa, Ontario
Saint John Regional Hosptial
Saint John, New Brunswick
About this study
Official title: A Multi-centre Randomized Control Trail Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Fractures.
Elderly patients with an intertrochanteric hip fracture will be randomized to receive either a sliding hip screw (SHS) (control group) or InterTAN intermedullary nail (IMN) (experimental group) for surgical fixation of their hip fracture. This study will assess functional and mortality outcomes for elderly patients with hip fractures.
Read the detailed description
Outcome after hip fracture in the elderly is generally poor. According to the World Health Organization, fracture of the hip is associated with 20 % 1-year mortality and 50 % loss of function33. However, the high mortality and loss of function can be improved. For example, numerous studies have shown improvement in relevant outcomes when interventions such as improved thromboprophylaxis, care pathways and timely surgery are achieved. Up to 50 % decreases in mortality can be achieved with these interventions1,2,3.
While improvements in perioperative care can improve outcome, the benefit of newer surgical techniques and implants is less clear. This is well demonstrated in the case of intertrochanteric fractures. Intertrochanteric fractures are those in which the primary fracture line occurs between the greater and lesser trochanter and include approximately 50 % of all hip fractures. Many surgical implants have been developed for this common fracture pattern; in general, the conventional implant is a sliding hip screw (SHS) in which a plate is fixed to the lateral cortex of the femur, distal to the fracture; and a large-diameter screw is placed in the centre of the femoral head, proximal to the fracture. The screw and plate slide relative to one another, permitting compression of the fracture and facilitating bone healing. In contrast, the newer implants are typically intramedullary nail designs (IMN), in which a metal nail is placed within the canal of the femur and a large-diameter screw is placed in the centre of the femoral head. The theoretical advantage of newer designs is based upon, first, an improved stability of the implant, allowing earlier and more aggressive mobilization; and second, a less invasive surgical procedure to minimize blood loss. Nonetheless, repeated trials and meta-analyses have failed to demonstrate an advantage to the IMN designs compared to SHS. In fact, perioperative complications seem to be higher using the IMN designs4,5.
There are two primary reasons why IMN designs have not translated into improved results to date. First, perioperative complications, especially fractures of the femur, are more common with current IMN designs. Second, the supposed improved stability conferred by these devices may not actually be achieved. Current IMN designs retain the original concept of a single screw in the femoral head, which does not prevent rotation of the femoral head - a common reason for implant failure. As well, most current IMN designs permit unrestricted axial shortening of the femur, which may lead to significant leg length changes and alter gait.
A new implant has been designed to take advantage of the inherent theoretical strengths of IMN designs and improve upon current design flaws. The InterTAN device (IT) has been designed to improve stability after fixation of intertrochanteric fractures. This device has a double proximal hip screw, to achieve rotational control; improved implant geometry, to improve immediate stability; and immediate compression to achieve stability while avoiding uncontrolled leg length changes. The IT device retains the percutaneous insertion technique of other IMN devices and simplifies insertion with redesigned instrumentation. The InterTAN device is the first device designed specifically to provide enhanced stability to intertrochanteric fractures and seems to offer significant promise compared to other IM designs.
The InterTAN device has not, as of yet, been compared to conventional surgical techniques. According to the Cochrane Database Reviews, "Any new design should be evaluated in a randomised comparison with the sliding hip screw."
- Conditions
- Hip Fractures
- Being tested
- sliding hip screw, IntertAn IM nail
- Keywords
- intertrochanteric hip fracture fixation, interTAN IM Nail, sliding hip 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.
sliding hip screwDevice
surgical repair of hip fracture using conventional sliding hip screw
IntertAn IM nailDevice
Also called InterTAn
interTAN IM nail
| Study group | Role | What they receive |
|---|---|---|
| SHS | Active comparator | sliding hip screw Receives: Device: sliding hip screw |
| InterTAn IM Nail | Active comparator | interTAN IM nail Receives: Device: IntertAn IM nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM)
Measured: prospective
Timed up an go (TUG)
Measured: prospective
Secondary outcomes (7)
2-minute walk test (2MWT)
Measured: prospective
Geriatric Depression Scale (GDS)
Measured: prospective
Lower Extremity Measure (LEM)
Measured: prospective
Complications
Measured: prospective
Femoral shortening
Measured: prospective
Blood Loss
Measured: prospective
Mortality
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startNov 2007
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Research Foundation
- Responsible party
- Principal investigator, David Sanders, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- David Sanders, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sDianne Bryant, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664950
- Sponsor's protocol ID
- R-08-002
- Other IDs
- 13619
- Status last verified
- Sep 2015
- First submitted
- 18 Apr 2008
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Randomized Control Trail Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Fractures.
- ClinicalTrials.gov ID
- NCT00664950
- Acronym / sponsor ID
- R-08-002
- Conditions
- Hip Fractures
- Keywords
- intertrochanteric hip fracture fixation, interTAN IM Nail, sliding hip screw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Orthopaedic Research Foundation
- Study start
- Nov 2007
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elderly patients with an intertrochanteric hip fracture will be randomized to receive either a sliding hip screw (SHS) (control group) or InterTAN intermedullary nail (IMN) (experimental group) for surgical fixation of their hip fracture. This study will assess functional and mortality outcomes for elderly patients with hip fractures.
Detailed description
Outcome after hip fracture in the elderly is generally poor. According to the World Health Organization, fracture of the hip is associated with 20 % 1-year mortality and 50 % loss of function33. However, the high mortality and loss of function can be improved. For example, numerous studies have shown improvement in relevant outcomes when interventions such as improved thromboprophylaxis, care pathways and timely surgery are achieved. Up to 50 % decreases in mortality can be achieved with these interventions1,2,3.
While improvements in perioperative care can improve outcome, the benefit of newer surgical techniques and implants is less clear. This is well demonstrated in the case of intertrochanteric fractures. Intertrochanteric fractures are those in which the primary fracture line occurs between the greater and lesser trochanter and include approximately 50 % of all hip fractures. Many surgical implants have been developed for this common fracture pattern; in general, the conventional implant is a sliding hip screw (SHS) in which a plate is fixed to the lateral cortex of the femur, distal to the fracture; and a large-diameter screw is placed in the centre of the femoral head, proximal to the fracture. The screw and plate slide relative to one another, permitting compression of the fracture and facilitating bone healing. In contrast, the newer implants are typically intramedullary nail designs (IMN), in which a metal nail is placed within the canal of the femur and a large-diameter screw is placed in the centre of the femoral head. The theoretical advantage of newer designs is based upon, first, an improved stability of the implant, allowing earlier and more aggressive mobilization; and second, a less invasive surgical procedure to minimize blood loss. Nonetheless, repeated trials and meta-analyses have failed to demonstrate an advantage to the IMN designs compared to SHS. In fact, perioperative complications seem to be higher using the IMN designs4,5.
There are two primary reasons why IMN designs have not translated into improved results to date. First, perioperative complications, especially fractures of the femur, are more common with current IMN designs. Second, the supposed improved stability conferred by these devices may not actually be achieved. Current IMN designs retain the original concept of a single screw in the femoral head, which does not prevent rotation of the femoral head - a common reason for implant failure. As well, most current IMN designs permit unrestricted axial shortening of the femur, which may lead to significant leg length changes and alter gait.
A new implant has been designed to take advantage of the inherent theoretical strengths of IMN designs and improve upon current design flaws. The InterTAN device (IT) has been designed to improve stability after fixation of intertrochanteric fractures. This device has a double proximal hip screw, to achieve rotational control; improved implant geometry, to improve immediate stability; and immediate compression to achieve stability while avoiding uncontrolled leg length changes. The IT device retains the percutaneous insertion technique of other IMN devices and simplifies insertion with redesigned instrumentation. The InterTAN device is the first device designed specifically to provide enhanced stability to intertrochanteric fractures and seems to offer significant promise compared to other IM designs.
The InterTAN device has not, as of yet, been compared to conventional surgical techniques. According to the Cochrane Database Reviews, "Any new design should be evaluated in a randomised comparison with the sliding hip screw."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHS | Active comparator | Device: sliding hip screwsliding hip screw |
| InterTAn IM Nail | Active comparator | Device: IntertAn IM nailinterTAN IM nail |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 55 years or greater*
- Intertrochanteric fracture amenable to treatment by sliding hip screw or intramedullary nail fixation
- Previously ambulatory (defined as not usually requiring a wheelchair for ambulation)*
- Provision of informed consent*
- Surgery performed within 72 hours of admission
Key exclusion criteria (5 listed)
- Cognitive or language barriers that would limit completion of assessment tests in English*
- Anticipated problems with follow-up in the judgment of the resident, or attending surgeon (e.g of no fixed address)*
- Surgeon refusal to randomize patient
- Pathologic fractures
- Polytrauma that would impact functional assessments in the opinion of the surgeon
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 |
|---|---|---|
| sliding hip screwsurgical repair of hip fracture using conventional sliding hip screw | Device | SHS |
| IntertAn IM nailAlso: InterTAninterTAN IM nail | Device | InterTAn IM Nail |
Primary outcome
Functional Independence Measure (FIM)
Time frame: prospective
Timed up an go (TUG)
Time frame: prospective
7 secondary outcomes
2-minute walk test (2MWT)
Time frame: prospective
Geriatric Depression Scale (GDS)
Time frame: prospective
Lower Extremity Measure (LEM)
Time frame: prospective
Complications
Time frame: prospective
Femoral shortening
Time frame: prospective
Blood Loss
Time frame: prospective
Mortality
Time frame: prospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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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.
David Sanders, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Dianne Bryant principal investigator
Western University, Canada
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sliding hip screw and IntertAn IM nail in people with Hip Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
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 5 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: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Independence Measure (FIM) (time frame: prospective). The study lists 2 primary outcomes in all. 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 Sep 2015.