Primary Knee ReplacementPhase 2NCT02117973
iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty Using the Persona Knee System Among Patients With BMI>=30: Radiographic, Clinical and Economic Outcomes
A Phase 2 study testing iAssist Technique using Persona system vs. the conventional technique using Persona system in people with Primary Knee Replacement, run by Hadassah Medical Organization.
Trial summary
The purpose of this prospective randomized study is to evaluate iAssist with respect to radiographic, clinical and economic outcomes in comparison to conventional instrumentation in primary total knee arthroplasty using the Persona knee system among patients with BMI>=30. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Primary Knee Replacement
- What is being tested?
- iAssist Technique using Persona system vs. the conventional technique using Persona system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2016
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Needs a primary TKR on the left or right knee
- Diagnose of non-inflammatory degenerative joint disease (e.g., osteoarthritis, post-traumatic arthritis, avascular necrosis, etc.)
- Over 18 years old
- BMI>=30
- Able to:
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- Understand what participation in the study entails and give written informed consent, and
- Follow surgeon/staff instructions, and
- Return for all follow-up evaluations, and
- Able and willing to undergo a preoperative full-leg, standing radiographs (all cases)
- Willing to consent (patient or his/her legal guardian) to participate in the study by signing and dating an approved consent.
- Meet an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.
- Presence of varus or valgus deformity of 15 degrees or less.
Who cannot join
- Currently enrolled in an investigational new drug or device study
- Active Infection (including septic knee, distant infection, or osteomyelitis)
- Severe hip arthrosis
- Neurological disorders (including, but not limited to Parkinson's disease)
- Prior ipsilateral unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
- Hip or knee ankylosis
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- Inflammatory joint disease.
- Either rheumatoid or post-traumatic knee arthritis
- Scheduled for simultaneous bilateral TKA
- Indications of intra- and/or extra-articular deformations that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, such as polio, history of tibial plateau fracture, etc.
- Any metal within 150 mm of the joint line for the operative-side knee
- Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination
- A female who is pregnant or lactating
- Current involvement in any personal injury litigation, medical-legal or worker's compensation claims
- Arterial disease or stents that would exclude the use of a tourniquet
- Insufficient quality or quantity of bone to support the implant due to prior knee surgery (or surgeries), cancer, metabolic bone disease, osteoporosis/osteopenia (diagnosed or treated with medication), active/old/remote infection, etc.
- Mental condition that may interfere with his/her ability to give an informed consent or interfere with his/her ability or willingness to fulfill the requirements of the study.
- Condition that would place excessive demands on the implant (e.g., Charcot's joints, muscle deficiencies, multiple joint disabilities, skeletal immaturity, etc.).
- Collateral ligament insufficiency.
- Immunosuppressive disorder (e.g., AIDS, etc.) that would require cytotoxic drugs, corticosteroids, large dose of irradiation, or antilymphocytic serum.
- An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this prospective randomized study is to evaluate iAssist with respect to radiographic, clinical and economic outcomes in comparison to conventional instrumentation in primary total knee arthroplasty using the Persona knee system among patients with BMI>=30.
- Conditions
- Primary Knee Replacement
- Being tested
- iAssist Technique using Persona system vs. the conventional technique using Persona system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iAssist Technique using Persona system vs. the conventional technique using Persona systemProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Conventional Technique using Persona prosthesis | Active comparator | The surgeon will realize the implantation of the Persona prosthesis according to the surgical technique. Potential variables such as methodology for determining tibial rotation, measuring of bone cuts, and any intra-operative adjustments will be captured on the operative case report form. Receives: Procedure: iAssist Technique using Persona system vs. the conventional technique using Persona system |
| iAssist Technique using Persona prosthesis | Experimental | iAssist is an electronic displacement sensor based instrumentation system that provides intra-operative verification at each surgical step (bone cuts alignment and resection level); in order to help reduce bone cuts errors. iAssist features simple and intuitive instrumentation that is based on conventional total knee arthroplasty instrumentation. iAssist should take less than 2-3 minutes (on average) to setup Receives: Procedure: iAssist Technique using Persona system vs. the conventional technique using Persona system |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in limb alignment
The primary endpoint is defined as Limb alignment as determined using radiographs (A/P long-standing and lateral films)
Measured: 12 MONTHS
Secondary outcomes (1)
difference in Knee Society Score
Assess the differences in Knee Society Score between iAssist and conventional instrumentation in primary TKA procedures.
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117973
- Sponsor's protocol ID
- 0092-13-HMO
- Status last verified
- Feb 2014
- First submitted
- 26 Feb 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty Using the Persona Knee System Among Patients With BMI>=30: Radiographic, Clinical and Economic Outcomes
- ClinicalTrials.gov ID
- NCT02117973
- Acronym / sponsor ID
- 0092-13-HMO
- Conditions
- Primary Knee Replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- First posted
- 21 Apr 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.
The purpose of this prospective randomized study is to evaluate iAssist with respect to radiographic, clinical and economic outcomes in comparison to conventional instrumentation in primary total knee arthroplasty using the Persona knee system among patients with BMI>=30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Technique using Persona prosthesis | Active comparator | Procedure: iAssist Technique using Persona system vs. the conventional technique using Persona systemThe surgeon will realize the implantation of the Persona prosthesis according to the surgical technique. Potential variables such as methodology for determining tibial rotation, measuring of bone cuts, and any intra-operative adjustments will be captured on the operative case report form. |
| iAssist Technique using Persona prosthesis | Experimental | Procedure: iAssist Technique using Persona system vs. the conventional technique using Persona systemiAssist is an electronic displacement sensor based instrumentation system that provides intra-operative verification at each surgical step (bone cuts alignment and resection level); in order to help reduce bone cuts errors. iAssist features simple and intuitive instrumentation that is based on conventional total knee arthroplasty instrumentation. iAssist should take less than 2-3 minutes (on average) to setup |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female
- Needs a primary TKR on the left or right knee
- Diagnose of non-inflammatory degenerative joint disease (e.g., osteoarthritis, post-traumatic arthritis, avascular necrosis, etc.)
- Over 18 years old
- BMI>=30
Key exclusion criteria (21 listed)
- Currently enrolled in an investigational new drug or device study
- Active Infection (including septic knee, distant infection, or osteomyelitis)
- Severe hip arthrosis
- Neurological disorders (including, but not limited to Parkinson's disease)
- Prior ipsilateral unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
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 |
|---|---|---|
| iAssist Technique using Persona system vs. the conventional technique using Persona system | Procedure or surgery | Conventional Technique using Persona prosthesis, iAssist Technique using Persona prosthesis |
Primary outcome
differences in limb alignment
Time frame: 12 MONTHS
The primary endpoint is defined as Limb alignment as determined using radiographs (A/P long-standing and lateral films)
1 secondary outcome
difference in Knee Society Score
Time frame: 12 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iAssist Technique using Persona system vs. the conventional technique using Persona system in people with Primary Knee Replacement, run by Hadassah Medical Organization.
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 13 inclusion and 21 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Meir Libergall, Prof. (972-2-6777111, liebergall@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in limb alignment (time frame: 12 MONTHS). 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 21 Apr 2014.