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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hip Osteoarthritis; Dislocation; Leg Length Discrepancy
• Intervention / Treatment: Device: Intellijoint HIP; Device: Outrigger

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesse I Wolfstadt, MD; Phone Number: 4167277374; Email: jesse.wolfstadt@mail.utoronto.ca
• Study Contact Backup: Name: Paul Kuzyk, MD; Email: paul.kuzyk@mtsinai.on.ca

Study Locations

• Canada
  • Ontario
    • Torono, Ontario, Canada, M5G 1X5
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Paul Kuzyk, MD; Phone Number: 4165864653; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of leg length	Standard post-operative anteroposterior pelvis radiographs will be used to assess the leg length discrepancy	6 weeks post-op
Accuracy of Hip Offset	Standard post-operative anteroposterior pelvis radiographs will be used to assess the hip offset restoration	6 weeks post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of surgery	We will measure the skin-to-closure time for each surgery to assess additional time, if any, added to procedure when using PelvAssist.	Measured at the time of surgery
Harris Hip Score	We will measure the Harris Hip Scores at 6 weeks and 1 year post-op.	1 year
Dislocation Rates	We will record the dislocation rates at one year following surgery.	1 Year
Oxford Hip Scores		6 weeks and 1 year post-op

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Investigators: Principal Investigator: Paul Kuzyk, MD, Mount Sinai Hospital, Division of Orthopedic Surgery

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: November 8, 2013
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Estimate): March 24, 2014
• Last Update Submitted That Met QC Criteria: March 20, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Navigation; THA; Total Hip Arthroplasty; Imageless; Computer navigated
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Pathological Conditions, Anatomical; Bone Diseases; Osteoarthritis; Bone Diseases, Developmental; Osteoarthritis, Hip; Leg Length Inequality
• Other Study ID Numbers: Intellijoint HIP