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

Mount Sinai Hospital, Canada

Status: Unknown

Conditions: Leg Length Discrepancy; Dislocation; Hip Osteoarthritis

Treatments: Device: Intellijoint HIP; Device: Outrigger

Study type: Interventional

Funder types: Other

Identifiers

NCT02095093

Intellijoint HIP

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Intellijoint HIP

Experimental group

Description:

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

Treatment:

Device: Intellijoint HIP

Outrigger

Active Comparator group

Description:

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.

Treatment:

Device: Outrigger