Knee ArthropathyNCT06969222
l Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)
A study testing Robotic TKA and Conventional TKA in people with Knee Arthropathy and Arthroplasty Complications, run by Orthopaedic Department of General University Hospital of Laria at 1 site in Greece.
Trial summary
This is a prospective trial that attempts to develop evidence on the safety and performance of RA-TKA (Robotic-assisted total knee arthroplasty) with Skywalker and eMP (Evolution Medial Pivot) knee. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthropathy, Arthroplasty Complications, Robotic Assisted Arthroplasty
- What is being tested?
- Robotic TKA and Conventional TKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteGreece
- Study dates
- 5 Sep 2023to 31 Dec 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 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >= 18 Years Male or Female
- With noninflammatory degenerative joint disease, inflammatory joint disease, functional deformity
- The subject has signed the Ethical Board approved Informed Consent Form specific to this study prior to enrollment
- Must be independent, ambulatory, and can comply with all post-operative evaluations and visits.
Who cannot join
- Subjects with poor compliance, unable to complete the trial according to the requirements or for other reasons or considered not to be suitable for inclusion by investigators.
- Concurrent participation in any other total hip or knee replacement studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Larisa
Larissa, Thessaly, 41334
Theofilos Karachalios, MD,PhD
About this study
Official title: A Prospective Clinical Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)
This is a prospective trial that attempts to develop evidence on the safety and performance of RA-TKA (Robotic-assisted total knee arthroplasty) with Skywalker and eMP (Evolution Medial Pivot) knee. Moreover to evaluate performance of eMP patients with Skywalker (in comparison to eMP with conventional instrumentations and non-MP TKAs)
Read the detailed description
The included patients will be those who meet study inclusion and exclusion criteria (IEC) to receive RA-TKA with Skywalker and eMP knees. This cohort will include learning curve cases from each surgeon. The learning curve cases will be determined based on the assessment of parameters such as surgical time etc.
Patients who have received eMP knees with conventional instrumentations or non-MP TKAs (retrospective)
Inclusion Criteria:
- >= 18 Years Male or Female
- With noninflammatory degenerative joint disease, inflammatory joint disease, functional deformity
- The subject has signed the Ethical Board approved Informed Consent Form specific to this study prior to enrollment
- Must be independent, ambulatory, and can comply with all post-operative evaluations and visits.
Exclusion Criteria:
- Subjects with poor compliance, unable to complete the trial according to the requirements or for other reasons or considered not to be suitable for inclusion by investigators.
- Concurrent participation in any other total hip or knee replacement studies.
Study Objectives: Evaluate Safety and Performance of RA-TKA with Skywalker and eMP knee and address research questions include but not limited to:
- Accuracy and Reproducibility of Skywalker with eMP knee
- Learning Curve of adopting Skywalker with eMP knees
- Postop function recovery in eMP patients with Skywalker
- Safety of eMP knee with Skywalker based on intra-op and postop complications
- (Enhanced) Kinematics of eMP with Skywalker compared to manual and other non MP TKA
Study Endpoints Primary Effectiveness Endpoints
- FJS and OKS at 12 months
- Kinematics from RSA at min 6 months
Primary Safety Endpoint
- Revisions / surgical interventions including MUA on the index knee due to any reasons
- Serious Adverse Events that require hospitalization
Secondary Endpoint
- Accuracy based on planned vs actual size and alignment parameters
- FJS at 6 weeks, 3 months, 6 months
- OKS at 6 weeks, 3 months, 6 months
- ROM from KSS at 6 weeks, 6 months and 12 months
- Learning Curve based on surgical time
- Being tested
- Robotic TKA, Conventional TKA
- Keywords
- knee arthroplasty, Skywalker robotic System, evolution medial pivot implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic TKAProcedure or surgery
Total knee replacement of arthritic knees either with robotic-assisted Skywalker device
Conventional TKAProcedure or surgery
Total knee replacement of arthritic knees performed manually
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted Skywalker device - Evolution Medial Pivot | Active comparator | Not described Receives: Procedure: Robotic TKA |
| Conventional total knee arthroplasty with manual instruments - device - Evolution Medial Pivot | Active comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
KOOS score(Knee Injury and Osteoarthritis Outcome Score) with a 0-100 scale measured at 1, 3, 6 and 12 months
Measured: 2 years after intervention
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
FJS (Forgotten Joint Score) with a scale 0 to 48 score measured at 1, 3, 6, and 12 months
Measured: 2 years after intervention
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
VAS score (Visual Analogue Scale) with a 0-10 scale measured at 1, 3, 6 and 12 months
Measured: 2 years after intervention
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
OKS score(Oxford Knee Score) with a 0-100 scale measured at 1, 3, 6 and 12 months
Measured: 2 years after intervention
Primary safety endpoints
Revisions / surgical interventions including MUA on the index knee due to any reason. Severe adverse effects
Measured: 1 year after intervention
Secondary outcomes (2)
Accuracy of implantation measured in degrees of correction
Accuracy based on planned vs actual size and alignment parameters
Measured: 1 year after intervention
Learning curve
Learning curve based on surgical time
Measured: 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start5 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee ArthropathyStudies 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
- prospective randomized trial with 122 patients divided into two groups One operated with robotic-assisted arthroplasty and other operated with conventional total knee arthroplasty
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Department of General University Hospital of Laria
- Sponsor type
- University, hospital or other
- Collaborators
- MicroPort Orthopedics Inc.
- Responsible party
- Principal investigator, Theofilos Karachalios, Orthopaedic Department of General University Hospital of Laria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969222
- Sponsor's protocol ID
- 50377/24-11-22
- Status last verified
- May 2025
- First submitted
- 2 Oct 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karachalios T, Varitimidis S, Bargiotas K, Hantes M, Roidis N, Malizos KN. An 11- to 15-year clinical outcome study of the Advance Medial Pivot total knee arthroplasty: pivot knee arthroplasty. Bone Joint J. 2016 Aug;98-B(8):1050-5. doi: 10.1302/0301-620X.98B8.36208.
PubMed 27482016St Mart JP, Goh EL. The current state of robotics in total knee arthroplasty. EFORT Open Rev. 2021 Apr 1;6(4):270-279. doi: 10.1302/2058-5241.6.200052. eCollection 2021 Apr.
PubMed 34040804Siddiqi A, Horan T, Molloy RM, Bloomfield MR, Patel PD, Piuzzi NS. A clinical review of robotic navigation in total knee arthroplasty: historical systems to modern design. EFORT Open Rev. 2021 Apr 1;6(4):252-269. doi: 10.1302/2058-5241.6.200071. eCollection 2021 Apr.
PubMed 34040803
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Investigation of Robotic-assisted TKA (RA-TKA) With Skywalker and Evolution Medial Pivot Knee (eMP Knee)
- ClinicalTrials.gov ID
- NCT06969222
- Acronym / sponsor ID
- 50377/24-11-22
- Keywords
- knee arthroplasty, Skywalker robotic System, evolution medial pivot implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Orthopaedic Department of General University Hospital of LariaUniversity, hospital or other
- Collaborators
- MicroPort Orthopedics Inc.
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 May 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 is a prospective trial that attempts to develop evidence on the safety and performance of RA-TKA (Robotic-assisted total knee arthroplasty) with Skywalker and eMP (Evolution Medial Pivot) knee. Moreover to evaluate performance of eMP patients with Skywalker (in comparison to eMP with conventional instrumentations and non-MP TKAs)
Detailed description
The included patients will be those who meet study inclusion and exclusion criteria (IEC) to receive RA-TKA with Skywalker and eMP knees. This cohort will include learning curve cases from each surgeon. The learning curve cases will be determined based on the assessment of parameters such as surgical time etc.
Patients who have received eMP knees with conventional instrumentations or non-MP TKAs (retrospective)
Inclusion Criteria:
- >= 18 Years Male or Female
- With noninflammatory degenerative joint disease, inflammatory joint disease, functional deformity
- The subject has signed the Ethical Board approved Informed Consent Form specific to this study prior to enrollment
- Must be independent, ambulatory, and can comply with all post-operative evaluations and visits.
Exclusion Criteria:
- Subjects with poor compliance, unable to complete the trial according to the requirements or for other reasons or considered not to be suitable for inclusion by investigators.
- Concurrent participation in any other total hip or knee replacement studies.
Study Objectives: Evaluate Safety and Performance of RA-TKA with Skywalker and eMP knee and address research questions include but not limited to:
- Accuracy and Reproducibility of Skywalker with eMP knee
- Learning Curve of adopting Skywalker with eMP knees
- Postop function recovery in eMP patients with Skywalker
- Safety of eMP knee with Skywalker based on intra-op and postop complications
- (Enhanced) Kinematics of eMP with Skywalker compared to manual and other non MP TKA
Study Endpoints Primary Effectiveness Endpoints
- FJS and OKS at 12 months
- Kinematics from RSA at min 6 months
Primary Safety Endpoint
- Revisions / surgical interventions including MUA on the index knee due to any reasons
- Serious Adverse Events that require hospitalization
Secondary Endpoint
- Accuracy based on planned vs actual size and alignment parameters
- FJS at 6 weeks, 3 months, 6 months
- OKS at 6 weeks, 3 months, 6 months
- ROM from KSS at 6 weeks, 6 months and 12 months
- Learning Curve based on surgical time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- prospective randomized trial with 122 patients divided into two groups One operated with robotic-assisted arthroplasty and other operated with conventional total knee arthroplasty
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted Skywalker device - Evolution Medial Pivot | Active comparator | Procedure: Robotic TKA |
| Conventional total knee arthroplasty with manual instruments - device - Evolution Medial Pivot | Active comparator | – |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >= 18 Years Male or Female
- With noninflammatory degenerative joint disease, inflammatory joint disease, functional deformity
- The subject has signed the Ethical Board approved Informed Consent Form specific to this study prior to enrollment
- Must be independent, ambulatory, and can comply with all post-operative evaluations and visits.
Key exclusion criteria (2 listed)
- Subjects with poor compliance, unable to complete the trial according to the requirements or for other reasons or considered not to be suitable for inclusion by investigators.
- Concurrent participation in any other total hip or knee replacement studies.
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 TKATotal knee replacement of arthritic knees either with robotic-assisted Skywalker device | Procedure or surgery | Robotic-assisted Skywalker device - Evolution Medial Pivot |
| Conventional TKATotal knee replacement of arthritic knees performed manually | Procedure or surgery | – |
Primary outcome
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
Time frame: 2 years after intervention
KOOS score(Knee Injury and Osteoarthritis Outcome Score) with a 0-100 scale measured at 1, 3, 6 and 12 months
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
Time frame: 2 years after intervention
FJS (Forgotten Joint Score) with a scale 0 to 48 score measured at 1, 3, 6, and 12 months
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
Time frame: 2 years after intervention
VAS score (Visual Analogue Scale) with a 0-10 scale measured at 1, 3, 6 and 12 months
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints
Time frame: 2 years after intervention
OKS score(Oxford Knee Score) with a 0-100 scale measured at 1, 3, 6 and 12 months
Primary safety endpoints
Time frame: 1 year after intervention
Revisions / surgical interventions including MUA on the index knee due to any reason. Severe adverse effects
2 secondary outcomes
Accuracy of implantation measured in degrees of correction
Time frame: 1 year after intervention
Learning curve
Time frame: 1 year after intervention
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 13 May 2025.
- Background: PubMed 27482016Karachalios T, Varitimidis S, Bargiotas K, Hantes M, Roidis N, Malizos KN. An 11- to 15-year clinical outcome study of the Advance Medial Pivot total knee arthroplasty: pivot knee arthroplasty. Bone Joint J. 2016 Aug;98-B(8):1050-5. doi: 10.1302/0301-620X.98B8.36208.
- Background: PubMed 34040804St Mart JP, Goh EL. The current state of robotics in total knee arthroplasty. EFORT Open Rev. 2021 Apr 1;6(4):270-279. doi: 10.1302/2058-5241.6.200052. eCollection 2021 Apr.
- Background: PubMed 34040803Siddiqi A, Horan T, Molloy RM, Bloomfield MR, Patel PD, Piuzzi NS. A clinical review of robotic navigation in total knee arthroplasty: historical systems to modern design. EFORT Open Rev. 2021 Apr 1;6(4):252-269. doi: 10.1302/2058-5241.6.200071. eCollection 2021 Apr.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic TKA and Conventional TKA in people with Knee Arthropathy and Arthroplasty Complications, run by Orthopaedic Department of General University Hospital of Laria at 1 site in Greece.
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 4 inclusion and 2 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 13 May 2025. 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 Greece. 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 Theofilos Karachalios, MD, PhD, Professor (+302413501199, kar@med.uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoints with outcome scores Primary Effectiveness Endpoints (time frame: 2 years after intervention). The study lists 5 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 NCT06969222, which also lists 3 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 13 May 2025.