An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mount Sinai Hospital, Canada
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT02095093
First received: November 8, 2013
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Hip Osteoarthritis
Leg Length Discrepancy
Dislocation
Device: Intellijoint HIP
Device: Outrigger

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intellijoint HIP Limited Release Trial: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Accuracy of leg length [ Time Frame: 6 weeks post-op ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Standard post-operative anteroposterior pelvis radiographs will be used to assess the hip offset restoration


Secondary Outcome Measures:
  • Time of surgery [ Time Frame: Measured at the time of surgery ] [ Designated as safety issue: No ]
    We will measure the skin-to-closure time for each surgery to assess additional time, if any, added to procedure when using PelvAssist.

  • Harris Hip Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will measure the Harris Hip Scores at 6 weeks and 1 year post-op.

  • Dislocation Rates [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    We will record the dislocation rates at one year following surgery.

  • Oxford Hip Scores [ Time Frame: 6 weeks and 1 year post-op ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: March 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intellijoint HIP
Patient's will have their leg length and hip offset determined intraoperatively using Intellijoint HIP.
Device: Intellijoint HIP
Intellijoint HIP is an intra-operative, imageless intelligent instrument used to provide real-time information to surgeons about leg length and hip offset changes during total hip replacement surgery.
Active Comparator: Outrigger
Control patients will have their leg length and hip offset determined intra-operatively using the standard at Mount Sinai Hospital, which is a pin and outrigger system.
Device: Outrigger
The outrigger is a pin and caliper device that is used to assess leg length and offset during total hip arthroplasty. It is the current standard of care at Mount Sinai Hospital.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT02095093

Contacts
Contact: Jesse I Wolfstadt, MD 4167277374 jesse.wolfstadt@mail.utoronto.ca
Contact: Paul Kuzyk, MD paul.kuzyk@mtsinai.on.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Torono, Ontario, Canada, M5G 1X5
Contact: Paul Kuzyk, MD    4165864653    pkuzyk@mtsinai.on.ca   
Sub-Investigator: Jesse I Wolfstadt, MD         
Principal Investigator: Paul Kuzyk, MD         
Sub-Investigator: David Backstein, MD         
Sub-Investigator: Oleg Safir, MD         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Paul Kuzyk, MD Mount Sinai Hospital, Division of Orthopedic Surgery
  More Information

No publications provided

Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02095093     History of Changes
Other Study ID Numbers: Intellijoint HIP
Study First Received: November 8, 2013
Last Updated: March 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
Total Hip Arthroplasty
Navigation
Imageless
THA
Computer navigated

Additional relevant MeSH terms:
Dislocations
Leg Length Inequality
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Bone Diseases
Bone Diseases, Developmental
Joint Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Rheumatic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014