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Clinical Trials/NCT02095093
NCT02095093
Unknown
Not Applicable

Intellijoint HIP Limited Release Trial: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty

Mount Sinai Hospital, Canada1 site in 1 country128 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
Mount Sinai Hospital, Canada
Enrollment
128
Locations
1
Primary Endpoint
Accuracy of leg length
Last Updated
12 years ago

Overview

Brief Summary

Leg length discrepancies following total hip arthroplasty have been associated with nerve palsies, gait abnormalities, and lower back pain. Leg length discrepancies are related to poorer functional outcomes and patient dissatisfaction. Failure to restore femoral offset following total hip arthroplasty has been linked to decreased range of motion and abductor muscle strength, impingement, limping, higher dislocation rates, increased polyethylene wear, and loosening of implants. Computer navigation has shown to improve the accuracy of leg length and hip offset during total hip arthroplasty. The investigators research objective is to prove the accuracy of the Intellijoint HIP™ system for determining leg length and hip offset. The investigators hypothesis was that Intellijoint HIP™, an imageless intraoperative intelligent instrument, could improve the accuracy of leg length and hip offset during primary total hip arthroplasty. The investigators plan to study this hypothesis in humans by comparing the leg length and hip offset discrepancies produced with Intellijoint HIP™ to the standard at the investigators institution, which is a pin and outrigger system.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
December 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Any patient who is undergoing a primary total hip arthroplasty at Mount Sinai Hospital.

Exclusion Criteria

  • Pre-operative flexion contracture \>30°, infection, or inability to achieve rigid fixation of instruments intra-operatively.

Outcomes

Primary Outcomes

Accuracy of leg length

Time Frame: 6 weeks post-op

Standard post-operative anteroposterior pelvis radiographs will be used to assess the leg length discrepancy

Accuracy of Hip Offset

Time Frame: 6 weeks post-op

Standard post-operative anteroposterior pelvis radiographs will be used to assess the hip offset restoration

Secondary Outcomes

  • Time of surgery(Measured at the time of surgery)
  • Harris Hip Score(1 year)
  • Dislocation Rates(1 Year)
  • Oxford Hip Scores(6 weeks and 1 year post-op)

Study Sites (1)

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