Knee OsteoarthritisNCT04769544
Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty
A study testing total knee arthroplasty with medial pivot tibial insert or symmetrical insert in people with Knee Osteoarthritis, run by Elda University Hospital at 1 site in Spain.
Trial summary
The functional outcome and longevity of total knee arthroplasty (TKA) is still a concern. Despite various developments in TKA designs, including fixed or mobile bearing, cruciate retaining or posterior stabilized, multi or single radius, it remains unclear which design is superior for achieving a physiological… Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- total knee arthroplasty with medial pivot tibial insert or symmetrical insert
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 31 Dec 2025
- 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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of the knee
- 50 years and older
- Participants must be able to give informed consent
Who cannot join
- Inflammatory arthritis
- Traumatic etiology
- Neurologic disease
- Neoplastic disease
- Morbid obesity
- Severe collateral ligament instability (> 10° varus/valgus)
Show all 10Show fewer
- Severe knee misalignment (greater than 10° of varus or valgus)
- Flexion contracture greater than 15º
- Prior surgery on the affected knee (except meniscus)
- Knee arthroplasty in the contralateral knee
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Elda University Hospital
Elda, Alicante, 03600
Alejandro Lizaur-Utrilla, PhD, MD, lizaur1@telefonica.net
Alejandro Lizaur-Utrilla, PhD, MD
About this study
Official title: Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty: A Randomized Controlled Study
The functional outcome and longevity of total knee arthroplasty (TKA) is still a concern. Despite various developments in TKA designs, including fixed or mobile bearing, cruciate retaining or posterior stabilized, multi or single radius, it remains unclear which design is superior for achieving a physiological kinematic.
In normal healthy knees the medial and lateral tibial condyles are different: the medial is almost flat while the lateral is somewhat convex. Thus, the movement during flexion is asymmetric: during the flexion, the medial condyle is stable throughout the range of motion while the lateral condyle slides anteroposteriorly with respect to femur). Therefore, the native knee requires a specific degree of rollback of the lateral compartment coupled with a medial pivot, which leads to an external axial rotation of the femur. This rollback is thought to be even more pronounced with increasing knee flexion angles to enable deep flexion without excessive shear forces acting at the patella or overloading the extensor mechanism.
Read more
In addition, stability throughout flexion is a crucial element to normal knee function. Most TKA designs removal of the ACL, and the PCL in posterior-stabilized design, but the TKA do not fully restore the function of those ligaments.
Based on this philosophy, the medial pivot TKA was designed to provide better function, patient satisfaction and increased survival.
The objective of this study is to analyze whether the medial pivot design provides better outcome and prosthesis survival than conventional total knee arthroplasty.
Read the detailed description
Candidates for the study will be consecutive patients eligible for total knee arthroplasty (TKA) at our center. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.
At that time, each patient will be randomized into one of two groups by an independent staff using computer generated randomization and allocation concealment. The two patient groups will include:
- Study group: patients treated with a medial pivot TKA.
- Control group: patients treated with a conventional TKA. Patients will be preoperatively assessed and postoperatively at regular intervals (6mo, 12 mo, and then annually) by orthopaedic surgeons not involved in the surgeries or cares.
- Conditions
- Knee Osteoarthritis
- Being tested
- total knee arthroplasty with medial pivot tibial insert or symmetrical insert
- Keywords
- knee osteoarthritis, Total knee arthroplasty, Medial pivot
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplasty with medial pivot tibial insert or symmetrical insertDevice
standard surgical implantation of total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Medial pivot group | Active comparator | Device used: medial pivot total knee arthroplasty design Receives: Device: total knee arthroplasty with medial pivot tibial insert or symmetrical insert |
| Conventional group | Active comparator | Device used: conventional total knee arthroplasty design Receives: Device: total knee arthroplasty with medial pivot tibial insert or symmetrical insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Knee Society Score
Functional KSS score (range 0-100) with higher scores as better outcome. A good result is defined as 70 points or greater
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be treated surgically with a TKA. The two patient groups will include: 1) Study group treated a medial pivot TKA; 2) Control group treated with a conventional TKA. Patients will be followed at regular postoperative intervals by orthopaedic surgeons not involved in the surgeries or cares.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elda University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche
- Responsible party
- Principal investigator, Alejandro Lizaur-Utrilla, PhD, MD, Elda University Hospital
- Investigators
- Alejandro Lizaur-Utrilla, MD, PhD, Principal investigator, Elda University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769544
- Sponsor's protocol ID
- MedialPivotPTR2021
- Status last verified
- Apr 2022
- First submitted
- 21 Feb 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04769544
- Acronym / sponsor ID
- MedialPivotPTR2021
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, Total knee arthroplasty, Medial pivot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Elda University HospitalUniversity, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Feb 2021 (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 functional outcome and longevity of total knee arthroplasty (TKA) is still a concern. Despite various developments in TKA designs, including fixed or mobile bearing, cruciate retaining or posterior stabilized, multi or single radius, it remains unclear which design is superior for achieving a physiological kinematic.
In normal healthy knees the medial and lateral tibial condyles are different: the medial is almost flat while the lateral is somewhat convex. Thus, the movement during flexion is asymmetric: during the flexion, the medial condyle is stable throughout the range of motion while the lateral condyle slides anteroposteriorly with respect to femur). Therefore, the native knee requires a specific degree of rollback of the lateral compartment coupled with a medial pivot, which leads to an external axial rotation of the femur. This rollback is thought to be even more pronounced with increasing knee flexion angles to enable deep flexion without excessive shear forces acting at the patella or overloading the extensor mechanism.
In addition, stability throughout flexion is a crucial element to normal knee function. Most TKA designs removal of the ACL, and the PCL in posterior-stabilized design, but the TKA do not fully restore the function of those ligaments.
Based on this philosophy, the medial pivot TKA was designed to provide better function, patient satisfaction and increased survival.
The objective of this study is to analyze whether the medial pivot design provides better outcome and prosthesis survival than conventional total knee arthroplasty.
Detailed description
Candidates for the study will be consecutive patients eligible for total knee arthroplasty (TKA) at our center. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.
At that time, each patient will be randomized into one of two groups by an independent staff using computer generated randomization and allocation concealment. The two patient groups will include:
- Study group: patients treated with a medial pivot TKA.
- Control group: patients treated with a conventional TKA. Patients will be preoperatively assessed and postoperatively at regular intervals (6mo, 12 mo, and then annually) by orthopaedic surgeons not involved in the surgeries or cares.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be treated surgically with a TKA. The two patient groups will include: 1) Study group treated a medial pivot TKA; 2) Control group treated with a conventional TKA. Patients will be followed at regular postoperative intervals by orthopaedic surgeons not involved in the surgeries or cares.
| Arm | Type | Receives |
|---|---|---|
| Medial pivot group | Active comparator | Device: total knee arthroplasty with medial pivot tibial insert or symmetrical insertDevice used: medial pivot total knee arthroplasty design |
| Conventional group | Active comparator | Device: total knee arthroplasty with medial pivot tibial insert or symmetrical insertDevice used: conventional total knee arthroplasty design |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary osteoarthritis of the knee
- 50 years and older
- Participants must be able to give informed consent
Key exclusion criteria (10 listed)
- Inflammatory arthritis
- Traumatic etiology
- Neurologic disease
- Neoplastic disease
- Morbid obesity
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 arthroplasty with medial pivot tibial insert or symmetrical insertstandard surgical implantation of total knee arthroplasty | Device | Conventional group, Medial pivot group |
Primary outcome
The Knee Society Score
Time frame: 2 years
Functional KSS score (range 0-100) with higher scores as better outcome. A good result is defined as 70 points or greater
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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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.
Alejandro Lizaur-Utrilla, MD, PhD principal investigator
Elda University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total knee arthroplasty with medial pivot tibial insert or symmetrical insert in people with Knee Osteoarthritis, run by Elda University Hospital 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 3 inclusion and 10 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 7 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Lizaur-Utrilla, MD, PhD (+34 966989019, lizaur1@telefonica.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Knee Society Score (time frame: 2 years). 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 7 Apr 2022.