An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
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|ClinicalTrials.gov Identifier: NCT02095093|
Recruitment Status : Unknown
Verified March 2014 by Mount Sinai Hospital, Canada.
Recruitment status was: Recruiting
First Posted : March 24, 2014
Last Update Posted : March 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hip Osteoarthritis Leg Length Discrepancy Dislocation||Device: Intellijoint HIP Device: Outrigger||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Intellijoint HIP Limited Release Trial: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2015|
Experimental: Intellijoint HIP
Patient's will have their leg length and hip offset determined intraoperatively using Intellijoint HIP.
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.
Active Comparator: 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.
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.
- Accuracy of leg length [ Time Frame: 6 weeks post-op ]Standard post-operative anteroposterior pelvis radiographs will be used to assess the leg length discrepancy
- Accuracy of Hip Offset [ Time Frame: 6 weeks post-op ]Standard post-operative anteroposterior pelvis radiographs will be used to assess the hip offset restoration
- Time of surgery [ Time Frame: Measured at the 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 [ Time Frame: 1 year ]We will measure the Harris Hip Scores at 6 weeks and 1 year post-op.
- Dislocation Rates [ Time Frame: 1 Year ]We will record the dislocation rates at one year following surgery.
- Oxford Hip Scores [ Time Frame: 6 weeks and 1 year post-op ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095093
|Contact: Jesse I Wolfstadt, MDemail@example.com|
|Contact: Paul Kuzyk, MDfirstname.lastname@example.org|
|Mount Sinai Hospital||Recruiting|
|Torono, Ontario, Canada, M5G 1X5|
|Contact: Paul Kuzyk, MD 4165864653 email@example.com|
|Sub-Investigator: Jesse I Wolfstadt, MD|
|Principal Investigator: Paul Kuzyk, MD|
|Sub-Investigator: David Backstein, MD|
|Sub-Investigator: Oleg Safir, MD|
|Principal Investigator:||Paul Kuzyk, MD||Mount Sinai Hospital, Division of Orthopedic Surgery|