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

NCT ID: NCT02095093

Last Updated: 2014-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31

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.

Conditions

Hip Osteoarthritis; Leg Length Discrepancy; Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intellijoint HIP

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

Group Type: EXPERIMENTAL

Intellijoint HIP

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Outrigger

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Kuzyk, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, Division of Orthopedic Surgery

Locations

Mount Sinai Hospital

Torono, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jesse I Wolfstadt, MD

Role: CONTACT

jesse.wolfstadt@mail.utoronto.ca

4167277374

Paul Kuzyk, MD

Role: CONTACT

paul.kuzyk@mtsinai.on.ca

Facility Contacts

Paul Kuzyk, MD

Role: primary

pkuzyk@mtsinai.on.ca

4165864653

Other Identifiers

Intellijoint HIP

Identifier Type: -

Identifier Source: org_study_id