Clinical Trials Directory

Trials / Unknown

UnknownNCT02095093

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
128 (estimated)
Sponsor
Mount Sinai Hospital, Canada · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEIntellijoint HIPIntellijoint 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.
DEVICEOutriggerThe 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.

Timeline

Start date
2014-03-01
Primary completion
2015-12-01
First posted
2014-03-24
Last updated
2014-03-24

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02095093. Inclusion in this directory is not an endorsement.