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.
Leg Length Discrepancy
Device: Intellijoint HIP
|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|
- 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
- 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 ]
|Study Start Date:||March 2014|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02095093
|Contact: Jesse I Wolfstadt, MDfirstname.lastname@example.org|
|Contact: Paul Kuzyk, MDemail@example.com|
|Mount Sinai Hospital||Recruiting|
|Torono, Ontario, Canada, M5G 1X5|
|Contact: Paul Kuzyk, MD 4165864653 firstname.lastname@example.org|
|Sub-Investigator: Jesse I Wolfstadt, MD|
|Principal Investigator: Paul Kuzyk, MD|
|Sub-Investigator: David Backstein, MD|
|Sub-Investigator: Oleg Safir, MD|
|Principal Investigator:||Paul Kuzyk, MD||Mount Sinai Hospital, Division of Orthopedic Surgery|