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

Hip Osteoarthritis Clinical Trial

Official title:

Intellijoint HIP Limited Release Trial: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02095093
• Other study ID #: Intellijoint HIP
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2013
• Last updated: March 20, 2014
• Start date: March 2014

Study information

• Verified date: March 2014
• Source: Mount Sinai Hospital, Canada
• Contact: Jesse I Wolfstadt, MD
• Phone: 4167277374
• Email: jesse.wolfstadt[@]mail.utoronto.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dislocation
• Dislocations
• Hip Osteoarthritis
• Leg Length Discrepancy
• Leg Length Inequality
• Osteoarthritis, Hip

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Torono	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of leg length	Standard post-operative anteroposterior pelvis radiographs will be used to assess the leg length discrepancy	6 weeks post-op	No
Primary	Accuracy of Hip Offset	Standard post-operative anteroposterior pelvis radiographs will be used to assess the hip offset restoration	6 weeks post-op	No
Secondary	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.	Measured at the time of surgery	No
Secondary	Harris Hip Score	We will measure the Harris Hip Scores at 6 weeks and 1 year post-op.	1 year	No
Secondary	Dislocation Rates	We will record the dislocation rates at one year following surgery.	1 Year	No
Secondary	Oxford Hip Scores		6 weeks and 1 year post-op	No