Avascular NecrosisNCT03111407
iAssist vs. Conventional Instrumentation in Total Knee Arthroplasty
A study testing total knee arthroplasty in people with Avascular Necrosis and Post-traumatic; Arthrosis, run by Zimmer, GmbH at 3 sites in 2 countries.
Trial summary
The purpose of this prospective study is to evaluate Zimmer® iASSIST™ with respect to radiographic, clinical and economic outcomes and compared to conventional instrumentation in primary total knee arthroplasty (NexGen or Persona knee implants). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Avascular Necrosis, Post-traumatic; Arthrosis, Knee Osteoarthritis
- What is being tested?
- total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is male or female
- Patient needs a primary total knee replacement using the NexGen LPS Flex or Persona knee implant
- Patient is diagnosed with non-inflammatory degenerative joint disease (e.g., osteoarthritis, post-traumatic arthritis, avascular necrosis, etc.)
- Patient is over 18 years old
- Patient is able to:
- Understand what participation in the study entails and willing to consent (patient or his/her legal guardian) to participate in the study by signing and dating an IRB/EC (ethics committee) approved inform consent form, and
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- Follow surgeon/staff instructions, and
- Return for all follow-up evaluations, and
- Able and willing to undergo a preoperative full-leg, standing radiographs and/or CT-scan
- Patient meets an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.
- Patient has a presence of varus or valgus deformity of 15 degrees or less.
Who cannot join
- Patient is currently enrolled in an investigational new drug or device study.
- Patient has an active infection (including septic knee, distant infection, or osteomyelitis).
- Patient has severe hip arthrosis.
- Patient has neurological disorders (including, but not limited to Parkinson's disease).
- Patient has had a prior ipsilateral unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy.
- Patient has hip or knee ankylosis.
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- Patient has inflammatory joint disease.
- Patient has rheumatoid knee arthritis.
- Patient has 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.
- Patient has any metal within 150 mm of the joint line for the operative-side knee.
- Patient has knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination.
- Female who is pregnant or lactating.
- Patient currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Patient has arterial disease or stents that would exclude the use of a tourniquet.
- Patient has 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.
- Patient has a 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.
- Patient has a condition that would place excessive demands on the implant (e.g., Charcot's joints, muscle deficiencies, multiple joint disabilities, skeletal immaturity, etc.).
- Patient has collateral ligament insufficiency.
- Patient has an immunosuppressive disorder (e.g., AIDS, etc.) that would require cytotoxic drugs, corticosteroids, large dose of irradiation, or antilymphocytic serum.
- Patient has an existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Hospital El Angel, S.A.
Málaga, 29007
Hospital Unviersitario Son Espases
Palma de Mallorca, 07010
About this study
Official title: Evaluation of Zimmer® iASSIST™ vs. Conventional Instrumentation in Total Knee Arthroplasty: Radiographic, Clinical and Economic Outcomes
The purpose of this prospective study is to evaluate Zimmer® iASSIST™ with respect to radiographic, clinical and economic outcomes and compared to conventional instrumentation in primary total knee arthroplasty (NexGen or Persona knee implants).
Read the detailed description
The study design is a prospective, multicenter, comparative outcome study. The study requires each site to obtain IRB (Institutional Review Board) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for 12 months. Follow-up clinical visits include 3 and 12 months post-operatively.
The primary endpoint of this study is defined as component alignment as determined using long leg X-Rays. The secondary endpoint will be to evaluate the Knee Society Score, EQ-5D (EuroQol-5Dimensions) scoring system, operating room time, blood loss and complications
- Being tested
- total knee arthroplasty
- Keywords
- primary total knee arthroplasty
- Medical subject headings
- Osteonecrosis, Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyProcedure or surgery
surgical procedure in which damaged parts of the knee joint are replaced with an implant.
| Study group | Role | What they receive |
|---|---|---|
| iAssist group | Other | patients will have primary total knee arthroplasty with the iAssist. The iAssist Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and implant components relative to these axes. Receives: Procedure: total knee arthroplasty |
| conventional instrumentation | Other | patients will have primary total knee arthroplasty with the conventional instrumentation. Receives: Procedure: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Component Alignment
Assess the differences in component alignment, measured by the mean of radiographs, between iASSIST™ and conventional instrumentation in primary total knee arthroplasty (TKA) procedures.
Measured: 1 year
Secondary outcomes (3)
Knee Society Score Assessment
Assess the differences in Knee Society Score between iASSIST™ and conventional instrumentation in primary TKA procedures. Higher (and better) score value: 100, lower value: 0.
Score 80-100 = Excellent Score 70-79 = Good Score 60-69 = Fair Score below 60 = Poor
Measured: 1 year
Knee Society Score Function
Knee Society Score function asses 12 months postoperatively between iASSIST™ and conventional instrumentation in primary TKA procedures. Higher (and better) score value: 100, lower value: 0.
Score 80-100 = Excellent Score 70-79 = Good Score 60-69 = Fair Score below 60 = Poor
Measured: 1 year
EQ-5D Questionnaire
Assess the differences in EQ-5D between iASSIST™ and conventional instrumentation in primary TKA procedures at 12 months postoperatively.
Comparison of the derived EQ-5D scale and health state between the 2 groups. The EQ-5D questionnaire includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
EQ-5D values range from -0.2 to 1 where the negative values correspond to bad health states (states worse than death), and 1.0 corresponds to perfect health.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startApr 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Avascular NecrosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups of patients: 1 will have the knee prosthesis implanted with iAssist and the other with conventional instrumentation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer, GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paola Vivoda, Ass.Direct, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111407
- Sponsor's protocol ID
- CSE2012-05K
- Status last verified
- Mar 2021
- First submitted
- 6 Apr 2017
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Zimmer® iASSIST™ vs. Conventional Instrumentation in Total Knee Arthroplasty: Radiographic, Clinical and Economic Outcomes
- ClinicalTrials.gov ID
- NCT03111407
- Acronym / sponsor ID
- CSE2012-05K
- Keywords
- primary total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Zimmer, GmbHIndustry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Posted 13 Apr 2021
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 study is to evaluate Zimmer® iASSIST™ with respect to radiographic, clinical and economic outcomes and compared to conventional instrumentation in primary total knee arthroplasty (NexGen or Persona knee implants).
Detailed description
The study design is a prospective, multicenter, comparative outcome study. The study requires each site to obtain IRB (Institutional Review Board) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for 12 months. Follow-up clinical visits include 3 and 12 months post-operatively.
The primary endpoint of this study is defined as component alignment as determined using long leg X-Rays. The secondary endpoint will be to evaluate the Knee Society Score, EQ-5D (EuroQol-5Dimensions) scoring system, operating room time, blood loss and complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups of patients: 1 will have the knee prosthesis implanted with iAssist and the other with conventional instrumentation.
| Arm | Type | Receives |
|---|---|---|
| iAssist group | Other | Procedure: total knee arthroplastypatients will have primary total knee arthroplasty with the iAssist. The iAssist Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and implant components relative to these axes. |
| conventional instrumentation | Other | Procedure: total knee arthroplastypatients will have primary total knee arthroplasty with the conventional instrumentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is male or female
- Patient needs a primary total knee replacement using the NexGen LPS Flex or Persona knee implant
- Patient is diagnosed with non-inflammatory degenerative joint disease (e.g., osteoarthritis, post-traumatic arthritis, avascular necrosis, etc.)
- Patient is over 18 years old
- Patient is able to:
Key exclusion criteria (20 listed)
- Patient is currently enrolled in an investigational new drug or device study.
- Patient has an active infection (including septic knee, distant infection, or osteomyelitis).
- Patient has severe hip arthrosis.
- Patient has neurological disorders (including, but not limited to Parkinson's disease).
- Patient has had a 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 |
|---|---|---|
| total knee arthroplastysurgical procedure in which damaged parts of the knee joint are replaced with an implant. | Procedure or surgery | conventional instrumentation, iAssist group |
Primary outcome
Component Alignment
Time frame: 1 year
Assess the differences in component alignment, measured by the mean of radiographs, between iASSIST™ and conventional instrumentation in primary total knee arthroplasty (TKA) procedures.
3 secondary outcomes
Knee Society Score Assessment
Time frame: 1 year
Knee Society Score Function
Time frame: 1 year
EQ-5D Questionnaire
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Paola Vivoda, Ass.Direct study director
Zimmer Biomet
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total knee arthroplasty in people with Avascular Necrosis and Post-traumatic; Arthrosis, run by Zimmer, GmbH at 3 sites in 2 countries.
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 11 inclusion and 20 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: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Switzerland. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Component Alignment (time frame: 1 year). 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 13 Apr 2021.