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

Not Applicable

• Conditions: Hip Osteoarthritis; Leg Length Discrepancy; Dislocation
• Interventions: Device: Intellijoint HIP; Device: Outrigger

• Registration Number: NCT02095093
• Lead Sponsor: Mount Sinai Hospital, Canada

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-08
• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted QC: 2014-03-20
• Last Update Submitted: 2014-03-20
• Study First Posted: 2014-03-24
• Last Update Posted: 2014-03-24
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intellijoint HIP	Intellijoint HIP	Patient's will have their leg length and hip offset determined intraoperatively using Intellijoint HIP.
Outrigger	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time of surgery	Measured at the 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.
Harris Hip Score	1 year	We will measure the Harris Hip Scores at 6 weeks and 1 year post-op.
Dislocation Rates	1 Year	We will record the dislocation rates at one year following surgery.
Oxford Hip Scores	6 weeks and 1 year post-op

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Torono, Ontario, Canada