InterTAN IM Nail Versus Sliding Hip Screw in Geriatric Fractures

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Orthopaedic Research Foundation
Information provided by (Responsible Party):
David Sanders, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00664950
First received: April 18, 2008
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hip Fractures
Device: sliding hip screw
Device: IntertAn IM nail

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre Randomized Control Trail Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Fractures.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Functional Independence Measure (FIM) [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Timed up an go (TUG) [ Time Frame: prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 2-minute walk test (2MWT) [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Geriatric Depression Scale (GDS) [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Lower Extremity Measure (LEM) [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Femoral shortening [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Blood Loss [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: prospective ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: November 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SHS
sliding hip screw
Device: sliding hip screw
surgical repair of hip fracture using conventional sliding hip screw
Active Comparator: InterTAn IM Nail
interTAN IM nail
Device: IntertAn IM nail
interTAN IM nail
Other Name: InterTAn

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."

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 55 years or greater*
  2. Intertrochanteric fracture amenable to treatment by sliding hip screw or intramedullary nail fixation
  3. Previously ambulatory (defined as not usually requiring a wheelchair for ambulation)*
  4. Provision of informed consent*
  5. Surgery performed within 72 hours of admission

Exclusion Criteria:

  1. Cognitive or language barriers that would limit completion of assessment tests in English*
  2. Anticipated problems with follow-up in the judgment of the resident, or attending surgeon (e.g of no fixed address)*
  3. Surgeon refusal to randomize patient
  4. Pathologic fractures
  5. Polytrauma that would impact functional assessments in the opinion of the surgeon
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664950

Locations
Canada, New Brunswick
Saint John Regional Hosptial
Saint John, New Brunswick, Canada
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Ottawa Civic Hospital
Ottawa, Ontario, Canada
Sponsors and Collaborators
Lawson Health Research Institute
Orthopaedic Research Foundation
Investigators
Principal Investigator: David Sanders, MD Lawson Health Research Institute
Principal Investigator: Dianne Bryant University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: David Sanders, MD, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00664950     History of Changes
Other Study ID Numbers: R-08-002, 13619
Study First Received: April 18, 2008
Last Updated: July 22, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
intertrochanteric hip fracture fixation
interTAN IM Nail
sliding hip screw

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 30, 2014