Dislocation, Hip Osteoarthritis, Leg Length Discrepancy
Conditions
Keywords
Total Hip Arthroplasty, Navigation, Imageless, THA, Computer navigated
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.
Interventions
DEVICEIntellijoint 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.
DEVICEOutrigger
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.
Sponsors
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Canada
Contacts
Primary ContactJesse I Wolfstadt, MD
Backup ContactPaul Kuzyk, MD
Outcome results
None listed