MedTrace Logo

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

NCT02095093 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2014-03-24

No results posted yet for this study

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

  • Hip Osteoarthritis
  • Leg Length Discrepancy
  • Dislocation

Interventions

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.

DEVICE

Outrigger

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 & Collaborators

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Paul Kuzyk, MD · Mount Sinai Hospital, Division of Orthopedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-12-31

Countries

  • Canada

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02095093 on ClinicalTrials.gov