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

NCT02095093 | Unknown

• 1 other identifier: Intellijoint HIP
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Keywords

Total Hip Arthroplasty; Navigation; Imageless; THA; Computer navigated

Outcome Measures

Primary Outcomes (2)

• Accuracy of leg length

  Standard post-operative anteroposterior pelvis radiographs will be used to assess the leg length discrepancy

  6 weeks post-op

• Accuracy of Hip Offset

  Standard post-operative anteroposterior pelvis radiographs will be used to assess the hip offset restoration

  6 weeks post-op

Secondary Outcomes (4)

• Time of surgery

  Measured at the time of surgery

• Harris Hip Score

  1 year

• Dislocation Rates

  1 Year

• Oxford Hip Scores

  6 weeks and 1 year post-op

Study Arms (2)

Intellijoint HIP

EXPERIMENTAL

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

Device: Intellijoint HIP

Outrigger

ACTIVE COMPARATOR

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.

Device: Outrigger

Interventions

Intellijoint HIP 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.

Intellijoint HIP

Outrigger 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.

Outrigger

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient who is undergoing a primary total hip arthroplasty at Mount Sinai Hospital.

You may not qualify if:

• Pre-operative flexion contracture \>30°, infection, or inability to achieve rigid fixation of instruments intra-operatively.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Torono, Ontario, M5G 1X5, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Leg Length Inequality; Joint Dislocations

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases, Developmental; Bone Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Paul Kuzyk, MD

  Mount Sinai Hospital, Division of Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesse I Wolfstadt, MD

CONTACT

4167277374; jesse.wolfstadt@mail.utoronto.ca

Paul Kuzyk, MD

CONTACT

paul.kuzyk@mtsinai.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: March 24, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

CA (1)