InterTAN IM Nail Versus Sliding Hip Screw in Geriatric Fractures
A Multi-centre Randomized Control Trail Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Fractures.
2 other identifiers
interventional
240
1 country
3
Brief 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. This study will assess functional and mortality outcomes for elderly patients with hip fractures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2007
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 18, 2008
CompletedFirst Posted
Study publicly available on registry
April 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 2, 2015
September 1, 2015
6.8 years
April 18, 2008
September 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Functional Independence Measure (FIM)
prospective
Timed up an go (TUG)
prospective
Secondary Outcomes (7)
2-minute walk test (2MWT)
prospective
Geriatric Depression Scale (GDS)
prospective
Lower Extremity Measure (LEM)
prospective
Complications
prospective
Femoral shortening
prospective
- +2 more secondary outcomes
Study Arms (2)
SHS
ACTIVE COMPARATORsliding hip screw
InterTAn IM Nail
ACTIVE COMPARATORinterTAN IM nail
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Saint John Regional Hosptial
Saint John, New Brunswick, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Ottawa Civic Hospital
Ottawa, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Sanders, MD
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- PRINCIPAL INVESTIGATOR
Dianne Bryant
Western University, Canada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 18, 2008
First Posted
April 23, 2008
Study Start
November 1, 2007
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
September 2, 2015
Record last verified: 2015-09