Hip OsteoarthritisNCT02095093
An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
A study testing Intellijoint HIP and Outrigger in people with Hip Osteoarthritis and Leg Length Discrepancy, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis, Leg Length Discrepancy, Dislocation
- What is being tested?
- Intellijoint HIP and Outrigger
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient who is undergoing a primary total hip arthroplasty at Mount Sinai Hospital.
Who cannot join
- Pre-operative flexion contracture >30°, infection, or inability to achieve rigid fixation of instruments intra-operatively.
Trial locations and contacts
1 site in 1 country.
Paul Kuzyk, MD contact
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Torono, Ontario, M5G 1X5
Paul Kuzyk, MD, 4165864653, pkuzyk@mtsinai.on.ca
Jesse I Wolfstadt, MD
About this study
Official title: Intellijoint HIP Limited Release Trial: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
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
- Being tested
- Intellijoint HIP, Outrigger
- Keywords
- Total Hip Arthroplasty, Navigation, Imageless, THA, Computer navigated
- Medical subject headings
- Osteoarthritis, Hip, Leg Length Inequality, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intellijoint HIPDevice
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.
OutriggerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intellijoint HIP | Experimental | Patient's will have their leg length and hip offset determined intraoperatively using Intellijoint HIP. Receives: 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. Receives: Device: Outrigger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of leg length
Standard post-operative anteroposterior pelvis radiographs will be used to assess the leg length discrepancy
Measured: 6 weeks post-op
Accuracy of Hip Offset
Standard post-operative anteroposterior pelvis radiographs will be used to assess the hip offset restoration
Measured: 6 weeks post-op
Secondary outcomes (4)
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: Measured at the time of surgery
Harris Hip Score
We will measure the Harris Hip Scores at 6 weeks and 1 year post-op.
Measured: 1 year
Dislocation Rates
We will record the dislocation rates at one year following surgery.
Measured: 1 Year
Oxford Hip Scores
Measured: 6 weeks and 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Kuzyk, MD, Principal investigator, Mount Sinai Hospital, Division of Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095093
- Sponsor's protocol ID
- Intellijoint HIP
- Status last verified
- Mar 2014
- First submitted
- 8 Nov 2013
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intellijoint HIP Limited Release Trial: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02095093
- Acronym / sponsor ID
- Intellijoint HIP
- Conditions
- Hip Osteoarthritis, Leg Length Discrepancy, Dislocation
- Keywords
- Total Hip Arthroplasty, Navigation, Imageless, THA, Computer navigated
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intellijoint HIP | Experimental | Device: Intellijoint HIPPatient's will have their leg length and hip offset determined intraoperatively using Intellijoint HIP. |
| Outrigger | Active comparator | Device: OutriggerControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who is undergoing a primary total hip arthroplasty at Mount Sinai Hospital.
Key exclusion criteria (1 listed)
- Pre-operative flexion contracture >30°, infection, or inability to achieve rigid fixation of instruments intra-operatively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intellijoint HIPIntellijoint 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. | Device | Intellijoint HIP |
| OutriggerThe 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. | Device | Outrigger |
Primary outcome
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
4 secondary outcomes
Time of surgery
Time frame: Measured at the time of surgery
Harris Hip Score
Time frame: 1 year
Dislocation Rates
Time frame: 1 Year
Oxford Hip Scores
Time frame: 6 weeks and 1 year post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Kuzyk, MD contact
Paul Kuzyk, MD principal investigator
Mount Sinai Hospital, Division of Orthopedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intellijoint HIP and Outrigger in people with Hip Osteoarthritis and Leg Length Discrepancy, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesse I Wolfstadt, MD (4167277374, jesse.wolfstadt@mail.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of leg length (time frame: 6 weeks post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.