Knee OsteoarthristisNCT06858358
Robotic Medial Congruent Vs. Conventional Medial Pivot TKA
A study testing Robotic assisted total knee arthroplasty and Conventional total knee arthroplasty (cTKA) in people with Knee Osteoarthristis, run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 2 sites in Romania.
Trial summary
This multicenter, prospective cohort study will evaluate whether Robotic-Assisted total knee arthroplasty (RATKA) with a Medial Congruent implant is a successful method to improve implant alignment, insert thickness accuracy, and patient satisfaction, compared to a conventional TKA (cTKA) Medial Pivot technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Robotic assisted total knee arthroplasty and Conventional total knee arthroplasty (cTKA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesRomania
- Study dates
- 24 Feb 2025to Sep 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with severe osteoarthritis (greater than III Ahlback)
Who cannot join
- Patients who refuse participation in the study Low-grade osteoarthritis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Romania2 sites, 2 recruiting
- Recruiting
MedLife Humanitas Hospital
Cluj-Napoca, Cluj, 400664
Razvan M Melinte, MD, PhD, +40 722 331 327, razvanmel@xnet.ro
- Recruiting
Medicover Cluj Hospital
Cluj-Napoca, Cluj, 407062
Horea Benea, MD, PhD, +40 724 528 188, programari.cluj@medicover.ro
About this study
Official title: Comparison of Robotic-Assisted Medial Congruent and Conventional Medial Pivot Total Knee Arthroplasty: a Prospective, Multicenter Analysis
This multicenter, prospective cohort study will evaluate whether Robotic-Assisted total knee arthroplasty (RATKA) with a Medial Congruent implant is a successful method to improve implant alignment, insert thickness accuracy, and patient satisfaction, compared to a conventional TKA (cTKA) Medial Pivot technique. It aims to assess and compare clinical and functional outcomes in patients with severe knee osteoarthritis at 3, 6, and 12 months.
Read the detailed description
This prospective, non-randomized, multicenter trial evaluates robotic-assisted (ROSA® Robotic Platform with Zimmer Biomet Persona® Medial Congruent) versus conventional (MicroPort Evolution® Medial-Pivot) total knee arthroplasty (TKA) in approximately 300 adults with severe osteoarthritis. By comparing robotic precision with a well-established Medial-Pivot design, this investigation aims to clarify whether robotic-assisted TKA confers superior implant positioning, reduced alignment outliers, and enhanced patient-reported outcomes (PROMS). The primary outcome measures include insert thickness, alignment accuracy (outliers defined as >2° from the mechanical axis on full-leg radiographs), and patient satisfaction at 6 and 12 months. Two surgeons will perform both techniques, and one surgeon will perform only the conventional procedure. The 18-month study is conducted under local Institutional Review Board approvals (Medlife, Medicover, SCJU Cluj Napoca, Monza Bucuresti) and complies with GDPR. Results are intended for publication in a high-impact orthopedic journal. No external funding is provided.
- Conditions
- Knee Osteoarthristis
- Being tested
- Robotic assisted total knee arthroplasty, Conventional total knee arthroplasty (cTKA)
- Keywords
- Robotic, Knee arthroplasty, TKA, ROSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic assisted total knee arthroplastyProcedure or surgery
- ROSA RATKA with Zimmer Biomet Persona Medial Congruent
Conventional total knee arthroplasty (cTKA)Procedure or surgery
cTKA with Microport Evolution Medial-Pivot
| Study group | Role | What they receive |
|---|---|---|
| ROSA Robotic-assisted TKA with Zimmer Biomet Persona Medial Congruent implant | Experimental | Not described Receives: Procedure: Robotic assisted total knee arthroplasty |
| Conventional TKA with Microport Evolution Medial-Pivot | Experimental | Not described Receives: Procedure: Conventional total knee arthroplasty (cTKA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyethylene insert thickness
Insert Thickness: Measured and analyzed in millimeters
Measured: Perioperative/ Periprocedural
Mechanical axis outliers
Outliers: Defined as more than 2.0 degrees from mechanical alignment, measured on full-leg X-ray
Measured: Perioperative/ Periprocedural
Secondary outcomes (2)
International knee documentation committe (IKDC) subjective score
The IKDC is a purely subjective assessment that assigns patients a functional overall rating. Three (3) categories are examined by the questionnaire: symptoms, athletic activity, and knee function. The symptoms subscale aids in evaluating issues like pain, stiffness, edema, and knee giving way.
The ICC, which varies from 0.87 to 0.98, was deemed sufficient (>0.70). Overall, it was discovered that the IKDC-SKF has positive test-retest reliability (Grevnerts et al. 2015). The IKDC subjective form scored acceptable for construct validity (84% confirmation of the predefined hypotheses) and responsiveness (86% confirmation of the predefined hypotheses) (van Meer et al. 2015).
Measured: 3, 6, and 12 months post-operative
Forgotten joint score-12 (FJS-12)
The primary objective of the FJS-12 is to evaluate the extent to which patients "forget" their artificial joints during daily activities. A higher score indicates that the patient is less aware of their joint, suggesting better surgical outcomes and higher levels of patient satisfaction.
Measured: 3, 6, and 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start24 Feb 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
- Sponsor type
- University, hospital or other
- Collaborators
- Iuliu Hatieganu University of Medicine and Pharmacy, County Clinical Emergency Hospital Cluj-Napoca
- Responsible party
- Principal investigator, Marian Andrei Melinte, George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858358
- Sponsor's protocol ID
- rosa_MP_MC_3002025
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Robotic-Assisted Medial Congruent and Conventional Medial Pivot Total Knee Arthroplasty: a Prospective, Multicenter Analysis
- ClinicalTrials.gov ID
- NCT06858358
- Acronym / sponsor ID
- rosa_MP_MC_3002025
- Conditions
- Knee Osteoarthristis
- Keywords
- Robotic, Knee arthroplasty, TKA, ROSA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu MuresUniversity, hospital or other
- Collaborators
- Iuliu Hatieganu University of Medicine and Pharmacy, County Clinical Emergency Hospital Cluj-Napoca
- Study start
- 24 Feb 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Mar 2025 (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.
This multicenter, prospective cohort study will evaluate whether Robotic-Assisted total knee arthroplasty (RATKA) with a Medial Congruent implant is a successful method to improve implant alignment, insert thickness accuracy, and patient satisfaction, compared to a conventional TKA (cTKA) Medial Pivot technique. It aims to assess and compare clinical and functional outcomes in patients with severe knee osteoarthritis at 3, 6, and 12 months.
Detailed description
This prospective, non-randomized, multicenter trial evaluates robotic-assisted (ROSA® Robotic Platform with Zimmer Biomet Persona® Medial Congruent) versus conventional (MicroPort Evolution® Medial-Pivot) total knee arthroplasty (TKA) in approximately 300 adults with severe osteoarthritis. By comparing robotic precision with a well-established Medial-Pivot design, this investigation aims to clarify whether robotic-assisted TKA confers superior implant positioning, reduced alignment outliers, and enhanced patient-reported outcomes (PROMS). The primary outcome measures include insert thickness, alignment accuracy (outliers defined as >2° from the mechanical axis on full-leg radiographs), and patient satisfaction at 6 and 12 months. Two surgeons will perform both techniques, and one surgeon will perform only the conventional procedure. The 18-month study is conducted under local Institutional Review Board approvals (Medlife, Medicover, SCJU Cluj Napoca, Monza Bucuresti) and complies with GDPR. Results are intended for publication in a high-impact orthopedic journal. No external funding is provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROSA Robotic-assisted TKA with Zimmer Biomet Persona Medial Congruent implant | Experimental | Procedure: Robotic assisted total knee arthroplasty |
| Conventional TKA with Microport Evolution Medial-Pivot | Experimental | Procedure: Conventional total knee arthroplasty (cTKA) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe osteoarthritis (greater than III Ahlback)
Key exclusion criteria (1 listed)
- Patients who refuse participation in the study Low-grade osteoarthritis
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 |
|---|---|---|
| Robotic assisted total knee arthroplasty• ROSA RATKA with Zimmer Biomet Persona Medial Congruent | Procedure or surgery | ROSA Robotic-assisted TKA with Zimmer Biomet Persona Medial Congruent implant |
| Conventional total knee arthroplasty (cTKA)cTKA with Microport Evolution Medial-Pivot | Procedure or surgery | Conventional TKA with Microport Evolution Medial-Pivot |
Primary outcome
Polyethylene insert thickness
Time frame: Perioperative/ Periprocedural
Insert Thickness: Measured and analyzed in millimeters
Mechanical axis outliers
Time frame: Perioperative/ Periprocedural
Outliers: Defined as more than 2.0 degrees from mechanical alignment, measured on full-leg X-ray
2 secondary outcomes
International knee documentation committe (IKDC) subjective score
Time frame: 3, 6, and 12 months post-operative
Forgotten joint score-12 (FJS-12)
Time frame: 3, 6, and 12 months post-operative
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 5 Mar 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic assisted total knee arthroplasty and Conventional total knee arthroplasty (cTKA) in people with Knee Osteoarthristis, run by George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures at 2 sites in Romania.
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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. 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 Marian A Melinte (+40 728 923 062, marianmelinte01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyethylene insert thickness (time frame: Perioperative/ Periprocedural). 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 5 Mar 2025.