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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip Osteoarthritis, Leg Length Discrepancy, Dislocation

Intervention / Treatment
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* Device: Intellijoint HIP
* Device: Outrigger


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intellijoint HIP<br>Patient's will have their leg length and hip offset determined intraoperatively using Intellijoint HIP. | Device: Intellijoint HIP<br>* 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.<br>|
| Active Comparator: Outrigger<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Arthroplasty, Navigation, Imageless, THA, Computer navigated