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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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 groups in NCT00664950
Study groupRoleWhat they receive
SHSActive comparatorsliding hip screw
Receives: Device: sliding hip screw
InterTAn IM NailActive comparatorinterTAN IM nail
Receives: Device: IntertAn IM nail

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Independence Measure (FIM)

    Measured: prospective

  2. Timed up an go (TUG)

    Measured: prospective

Secondary outcomes (7)
  1. 2-minute walk test (2MWT)

    Measured: prospective

  2. Geriatric Depression Scale (GDS)

    Measured: prospective

  3. Lower Extremity Measure (LEM)

    Measured: prospective

  4. Complications

    Measured: prospective

  5. Femoral shortening

    Measured: prospective

  6. Blood Loss

    Measured: prospective

  7. Mortality

    Measured: prospective

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2008 (estimated)
  2. Study startNov 2007
  3. Primary completionAug 2014
  4. Study completionDec 2014

Resources

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)
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

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.

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