An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
Primary Purpose
Hip Osteoarthritis, Leg Length Discrepancy, Dislocation
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intellijoint HIP
Outrigger
Sponsored by
About this trial
This is an interventional prevention trial for Hip Osteoarthritis focused on measuring Total Hip Arthroplasty, Navigation, Imageless, THA, Computer navigated
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.
Sites / Locations
- Mount Sinai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intellijoint HIP
Outrigger
Arm Description
Patient's will have their leg length and hip offset determined intraoperatively using Intellijoint HIP.
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.
Outcomes
Primary Outcome Measures
Accuracy of leg length
Standard post-operative anteroposterior pelvis radiographs will be used to assess the leg length discrepancy
Accuracy of Hip Offset
Standard post-operative anteroposterior pelvis radiographs will be used to assess the hip offset restoration
Secondary Outcome Measures
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.
Harris Hip Score
We will measure the Harris Hip Scores at 6 weeks and 1 year post-op.
Dislocation Rates
We will record the dislocation rates at one year following surgery.
Oxford Hip Scores
Full Information
NCT ID
NCT02095093
First Posted
November 8, 2013
Last Updated
March 20, 2014
Sponsor
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT02095093
Brief Title
An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
Official Title
Intellijoint HIP Limited Release Trial: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Leg Length Discrepancy, Dislocation
Keywords
Total Hip Arthroplasty, Navigation, Imageless, THA, Computer navigated
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intellijoint HIP
Arm Type
Experimental
Arm Description
Patient's will have their leg length and hip offset determined intraoperatively using Intellijoint HIP.
Arm Title
Outrigger
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Intellijoint HIP
Intervention Description
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
Intervention Name(s)
Outrigger
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accuracy of leg length
Description
Standard post-operative anteroposterior pelvis radiographs will be used to assess the leg length discrepancy
Time Frame
6 weeks post-op
Title
Accuracy of Hip Offset
Description
Standard post-operative anteroposterior pelvis radiographs will be used to assess the hip offset restoration
Time Frame
6 weeks post-op
Secondary Outcome Measure Information:
Title
Time of surgery
Description
We will measure the skin-to-closure time for each surgery to assess additional time, if any, added to procedure when using PelvAssist.
Time Frame
Measured at the time of surgery
Title
Harris Hip Score
Description
We will measure the Harris Hip Scores at 6 weeks and 1 year post-op.
Time Frame
1 year
Title
Dislocation Rates
Description
We will record the dislocation rates at one year following surgery.
Time Frame
1 Year
Title
Oxford Hip Scores
Time Frame
6 weeks and 1 year post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse I Wolfstadt, MD
Phone
4167277374
Email
jesse.wolfstadt@mail.utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Kuzyk, MD
Email
paul.kuzyk@mtsinai.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Kuzyk, MD
Organizational Affiliation
Mount Sinai Hospital, Division of Orthopedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Torono
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Kuzyk, MD
Phone
4165864653
Email
pkuzyk@mtsinai.on.ca
First Name & Middle Initial & Last Name & Degree
Jesse I Wolfstadt, MD
First Name & Middle Initial & Last Name & Degree
Paul Kuzyk, MD
First Name & Middle Initial & Last Name & Degree
David Backstein, MD
First Name & Middle Initial & Last Name & Degree
Oleg Safir, MD
12. IPD Sharing Statement
Learn more about this trial
An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
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