Knee Arthroplasty, TotalNCT05516381
Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment
A study testing Optetrak Logic CR Knee System in people with Knee Arthroplasty, Total, run by Exactech at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Optetrak Logic CR Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subjects must meet all of the following inclusion criteria to be included in the study:
- Subject must be at least 18 years of age at the time of the surgery (skeletally mature)
- Subject will receive a Optetrak Logic® CR device per the "Indications for Use" described above
- Subject must be willing to comply with the pre-operative and post-operative visit requirements
- Subject must be willing and able to provide written informed consent for participation in the study
Who cannot join
- Subjects will be excluded from the study if they meet any of the following exclusion criteria:
- Subject with a suspected or confirmed systemic infection and/or a secondary remote infection
- Subject without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
- Subject without sufficient soft tissue integrity to provide adequate stability
- Subject with either mental or neuromuscular disorders that do not allow control of the knee joint
- Subjects whose weight, age, or activity level might cause extreme loads and early failure of the system
Show all 13Show fewer
- Subject is participating in another drug or device study other than knee replacement within the last three (3) months
- Subject has behavioral and/or mental issues that may interfere with their ability to follow post-operative instructions
- Subject is a prisoner
- Subject is pregnant
- Subject is undergoing radiation therapy where the targeted field involves the knee joint
- Subjects with malignancy involving proximal tibia, distal femur, or knee joint
- Subjects undergoing active administration of chemotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amanda Ford, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C.
Barcelona
Pilar A Sola, 93 736 50 50 ext. 11801, parcusa@muturterrassa.es
About this study
Official title: Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study
The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.
Read the detailed description
A prospective randomized clinical study will be conducted.
The study will consist of two cohorts and will collect clinical data from a maximum of 148 knee arthroplasty surgeries during which the patient will receive the Optetrak Logic® CR TKA device. Cohorts will consist of 1) subjects undergoing MA TKA and 2) subjects undergoing restricted iKA TKA. All cohorts will utilize navigation-assisted surgery (ExactechGPS®) and will be enrolled and consented concurrently. Subjects will be randomized and have a 50% chance of being assigned to the MA TKA cohort and a 50% chance of being assigned to the restricted iKA TKA cohort. Study and research staff will be blinded to randomization and the cohort allocation until after consenting and eligibility is determined. Subjects will be blinded to the randomization (MA TKA or restricted iKA TKA) until the completion of the study.
Data collection under this protocol shall be conducted in a way that conforms to any applicable local and national rules, regulations, and guidelines relating to the conduct of clinical research and the protection of human subjects. As appropriate, this may include but is not limited to the following: Good Clinical Practice (GCP) requirements, FDA regulations and guidelines, ISO 14155: 2020, ICH guidelines, HIPAA and other regulations pertaining to the protection of patient data and data privacy, guidelines established by local Institutional Review Boards or similar Ethics Committees, the Belmont Report, and the Declaration of Helsinki.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Optetrak Logic CR Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optetrak Logic CR Knee SystemDevice
Also called Exactech Guided Personalized Surgery
The OPTETRAK® Comprehensive Knee System consists of the OPTETRAK® Total Knee System and the OPTETRAK Logic® Total Knee System. The OPTETRAK Comprehensive Knee System comprises both non-porous and porous knee prostheses for use in total-knee joint replacement procedures. (In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.) The system includes various sizes and types of modular femoral components, tibial components, patellar components, and accessories for use in primary and revision applications.
| Study group | Role | What they receive |
|---|---|---|
| Restricted Invers Kinematic Knee Alignment Technique | Other | Restricted Invers Kinematic Knee Alignment Technique Receives: Device: Optetrak Logic CR Knee System |
| Mechanical Knee Alignment Technique | Other | Mechanical Knee Alignment Technique Receives: Device: Optetrak Logic CR Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score (KSS)
Validated outcome score
Measured: 3-month
Knee Society Score (KSS)
Validated outcome score
Measured: 6-month
Knee Society Score (KSS)
Validated outcome score
Measured: 12-month
Forgotten Joint Score (FJS)
Validated outcome score
Measured: 3-month
Forgotten Joint Score (FJS)
Validated outcome score
Measured: 6-month
Forgotten Joint Score (FJS)
Validated outcome score
Measured: 12-month
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Validated outcome score
Measured: 3-month
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Validated outcome score
Measured: 6-month
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Validated outcome score
Measured: 12-month
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (low score is better)
Measured: 3-month
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (low score is better)
Measured: 6-month
Visual Analog Scale (VAS) - Pain
Visual scale from 1-10 (low score is better)
Measured: 12-month
Visual Analog Scale (VAS) - Patient Satisfaction
Visual scale from 1-10 (high score is better)
Measured: 3-month
Visual Analog Scale (VAS) - Patient Satisfaction
Visual scale from 1-10 (high score is better)
Measured: 6-month
Visual Analog Scale (VAS) - Patient Satisfaction
Visual scale from 1-10 (high score is better)
Measured: 12-month
Secondary outcomes (1)
Knee Alignment
Characterization of knee in terms of ligament balancing will be assessed through constant-pressure full arc of motion measurement.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start15 May 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee Arthroplasty, TotalStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomization list (block randomized, computer generated, two equal-size groups) will be created within the EDC system
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Mateu-Vincent, Medical Degree, Principal investigator, Orthpaedic Surgeon Hospital Universitaria Mutua Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516381
- Sponsor's protocol ID
- TM-2021-1586
- Status last verified
- Jun 2024
- First submitted
- 19 Aug 2022
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There are no plans to share individual participant data
Publications
Winnock de Grave P, Luyckx T, Claeys K, Tampere T, Kellens J, Muller J, Gunst P. Higher satisfaction after total knee arthroplasty using restricted inverse kinematic alignment compared to adjusted mechanical alignment. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):488-499. doi: 10.1007/s00167-020-06165-4. Epub 2020 Jul 31.
PubMed 32737528Almaawi AM, Hutt JRB, Masse V, Lavigne M, Vendittoli PA. The Impact of Mechanical and Restricted Kinematic Alignment on Knee Anatomy in Total Knee Arthroplasty. J Arthroplasty. 2017 Jul;32(7):2133-2140. doi: 10.1016/j.arth.2017.02.028. Epub 2017 Feb 20.
PubMed 28302462
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05516381
- Acronym / sponsor ID
- TM-2021-1586
- Conditions
- Knee Arthroplasty, Total
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Aug 2022 (actual)
- 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 study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.
Detailed description
A prospective randomized clinical study will be conducted.
The study will consist of two cohorts and will collect clinical data from a maximum of 148 knee arthroplasty surgeries during which the patient will receive the Optetrak Logic® CR TKA device. Cohorts will consist of 1) subjects undergoing MA TKA and 2) subjects undergoing restricted iKA TKA. All cohorts will utilize navigation-assisted surgery (ExactechGPS®) and will be enrolled and consented concurrently. Subjects will be randomized and have a 50% chance of being assigned to the MA TKA cohort and a 50% chance of being assigned to the restricted iKA TKA cohort. Study and research staff will be blinded to randomization and the cohort allocation until after consenting and eligibility is determined. Subjects will be blinded to the randomization (MA TKA or restricted iKA TKA) until the completion of the study.
Data collection under this protocol shall be conducted in a way that conforms to any applicable local and national rules, regulations, and guidelines relating to the conduct of clinical research and the protection of human subjects. As appropriate, this may include but is not limited to the following: Good Clinical Practice (GCP) requirements, FDA regulations and guidelines, ISO 14155: 2020, ICH guidelines, HIPAA and other regulations pertaining to the protection of patient data and data privacy, guidelines established by local Institutional Review Boards or similar Ethics Committees, the Belmont Report, and the Declaration of Helsinki.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomization list (block randomized, computer generated, two equal-size groups) will be created within the EDC system
| Arm | Type | Receives |
|---|---|---|
| Restricted Invers Kinematic Knee Alignment Technique | Other | Device: Optetrak Logic CR Knee SystemRestricted Invers Kinematic Knee Alignment Technique |
| Mechanical Knee Alignment Technique | Other | Device: Optetrak Logic CR Knee SystemMechanical Knee Alignment Technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must meet all of the following inclusion criteria to be included in the study:
Key exclusion criteria (13 listed)
- Subjects will be excluded from the study if they meet any of the following exclusion criteria:
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 |
|---|---|---|
| Optetrak Logic CR Knee SystemAlso: Exactech Guided Personalized SurgeryThe OPTETRAK® Comprehensive Knee System consists of the OPTETRAK® Total Knee System and the OPTETRAK Logic® Total Knee System. The OPTETRAK Comprehensive Knee System comprises both non-porous and porous knee prostheses for use in total-knee joint replacement procedures. (In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.) The system includes various sizes and types of modular femoral components, tibial components, patellar components, and accessories for use in primary and revision applications. | Device | Mechanical Knee Alignment Technique, Restricted Invers Kinematic Knee Alignment Technique |
Primary outcome
Knee Society Score (KSS)
Time frame: 3-month
Validated outcome score
Knee Society Score (KSS)
Time frame: 6-month
Validated outcome score
Knee Society Score (KSS)
Time frame: 12-month
Validated outcome score
Forgotten Joint Score (FJS)
Time frame: 3-month
Validated outcome score
Forgotten Joint Score (FJS)
Time frame: 6-month
Validated outcome score
Forgotten Joint Score (FJS)
Time frame: 12-month
Validated outcome score
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 3-month
Validated outcome score
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6-month
Validated outcome score
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12-month
Validated outcome score
Visual Analog Scale (VAS) - Pain
Time frame: 3-month
Visual scale from 1-10 (low score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 6-month
Visual scale from 1-10 (low score is better)
Visual Analog Scale (VAS) - Pain
Time frame: 12-month
Visual scale from 1-10 (low score is better)
Visual Analog Scale (VAS) - Patient Satisfaction
Time frame: 3-month
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Patient Satisfaction
Time frame: 6-month
Visual scale from 1-10 (high score is better)
Visual Analog Scale (VAS) - Patient Satisfaction
Time frame: 12-month
Visual scale from 1-10 (high score is better)
1 secondary outcome
Knee Alignment
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 32737528Winnock de Grave P, Luyckx T, Claeys K, Tampere T, Kellens J, Muller J, Gunst P. Higher satisfaction after total knee arthroplasty using restricted inverse kinematic alignment compared to adjusted mechanical alignment. Knee Surg Sports Traumatol Arthrosc. 2022 Feb;30(2):488-499. doi: 10.1007/s00167-020-06165-4. Epub 2020 Jul 31.
- Background: PubMed 28302462Almaawi AM, Hutt JRB, Masse V, Lavigne M, Vendittoli PA. The Impact of Mechanical and Restricted Kinematic Alignment on Knee Anatomy in Total Knee Arthroplasty. J Arthroplasty. 2017 Jul;32(7):2133-2140. doi: 10.1016/j.arth.2017.02.028. Epub 2017 Feb 20.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data
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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.
Amanda Ford, PhD contact
David Mateu-Vincent, Medical Degree principal investigator
Orthpaedic Surgeon Hospital Universitaria Mutua Terrassa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optetrak Logic CR Knee System in people with Knee Arthroplasty, Total, run by Exactech at 1 site in Spain.
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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 18 Jun 2024. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Knisely, BSBA (352-474-9582, alex.knisely@exac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score (KSS) (time frame: 3-month). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516381, which also lists 2 linked publications.
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 18 Jun 2024.