Loosening, ProsthesisNCT05204797
Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After UKA
A study testing Robot-assisted UKA and Standard technique UKA in people with Loosening, Prosthesis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The purpose of this study is to compare the percentage of early micromibilisation in unicompartmental knee arthroplasties in robot-assisted technique vs standard technique. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Loosening, Prosthesis
- What is being tested?
- Robot-assisted UKA and Standard technique UKA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 7 Oct 2021to Dec 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unicompartmental Knee Arthrosis
- Femoral condyles or medial tibial plate osteonecrosis
- Healthy anterior cruciate ligament, posterior cruciate ligament and collateral ligaments of the affected knee
- Post traumatic loss of joint configuration
- Moderate varism deformity
- Patients between 50 and 80 years old
- Patients able to undergo a 2-year follow up after surgery
Who cannot join
- Bi or Tricompartmental arthrosis
- Unhealty anterior or posterior cruciate ligaments or collateral ligaments
- Patients with neuromuscolar, degenerative and joint-related conditions
- Patients younger than 50
- Patients older than 80
- Patients unable to undergo a 2-year follow up after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After Unicompartmental Knee Arthroplasty: a Controlled Randomized Trial
The purpose of this study is to compare the percentage of early micromibilisation in unicompartmental knee arthroplasties in robot-assisted technique vs standard technique.
Read the detailed description
The purpose of the study is to compare the percentage of early micromobilisation by static radiostereometric analysis (RSA) - primary outcome, gait analysis by inertial sensors to assess gait kinematics, and clinical perdormance measured by american knee society score (AKSS), oxford knee score (OKS), patient satisfaction score (PSS) and EQ5-D - secondary outcomes, among 2 groups of patients, of 25 individuals each, whi undergo medial unicompartmental knee arthroplasty.
The first group will be operated with a robot-assisted technique (with CORI Surgical System, Smith and Nephew, USA), the other with standard technique and the same implant (Journey UNI II, Smith and Nephew, USA).
The study will be a randomized and controlled blind superiority trial. Patients will not be informed about performing the surgery with one technique or the other in order to avoid potential biases in the data analysis.
Patients will be recruited at the orthoaedic and traumatologic 2nd clinica (head prof S. Zaffagnini) at IRCSS Istituto Ortopedico Rizzoli in Bologna, Italy.
- Conditions
- Loosening, Prosthesis
- Being tested
- Robot-assisted UKA, Standard technique UKA
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted UKAProcedure or surgery
Also called CORI Surgical System, Smith and Nephew
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients.
Standard technique UKAProcedure or surgery
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted UKA | Experimental | Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via CORI surgical system (Smith \& Nephew, USA). Receives: Procedure: Robot-assisted UKA |
| Standard technique UKA | Active comparator | Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via standard technique. Receives: Procedure: Standard technique UKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Measured: Within 7 days from surgery, during hospitalisation
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Measured: 3 months
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Measured: 6 months
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Measured: 12 months
Static radiostereometric analysis (RSA)
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Measured: 24 months
Secondary outcomes (7)
Gait analysis via inertial sensors
Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.
Measured: Within 7 days from surgery, during hospitalisation
Gait analysis via inertial sensors
Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.
Measured: 6 months
Gait analysis via inertial sensors
Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis.
Measured: 24 months
American Knee Society score
Used to test knee function by the investigator: it has a clinical and a functional part
Measured: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Oxford Knee Score
Consists of 12 questions to be filled by the patient to assess how the prosthesis affect activities of daily living.
Measured: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Patient Satisfaction Score
A short personal questionnaire that assesses subjective satisfaction after surgery
Measured: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
EQ5-D questionnaire
a questionnaire filled by the patient assessing the overall health of the subject. It is a test used to assess quality of life index.
Measured: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start7 Oct 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loosening, ProsthesisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two blinded groups operated via robotic-assisted surgery (1st arm) or conventional technique (2nd arm).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
- Investigators
- Stefano Zaffagnini, Prof., Principal investigator, IRCCS Istituto Ortopedico RizzoliGiulio Maria Marcheggiani Muccioli, Prof., Study director, IRCCS Istituto Ortopedico RizzoliStefano Fratini, Dr., Study chair, IRCCS Istituto Ortopedico RizzoliStefano Di Paolo, Eng., Study chair, University of BolognaLaura Bragonzoni, Dr., Study chair, University of BolognaRaffaele Zinno, Dr., Study chair, University of BolognaGiuseppe Barone, Dr., Study chair, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204797
- Sponsor's protocol ID
- RSA UNI CORI
- Status last verified
- Jan 2026
- First submitted
- 27 Sep 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing planned
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After Unicompartmental Knee Arthroplasty: a Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT05204797
- Acronym / sponsor ID
- RSA UNI CORI
- Conditions
- Loosening, Prosthesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jan 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 compare the percentage of early micromibilisation in unicompartmental knee arthroplasties in robot-assisted technique vs standard technique.
Detailed description
The purpose of the study is to compare the percentage of early micromobilisation by static radiostereometric analysis (RSA) - primary outcome, gait analysis by inertial sensors to assess gait kinematics, and clinical perdormance measured by american knee society score (AKSS), oxford knee score (OKS), patient satisfaction score (PSS) and EQ5-D - secondary outcomes, among 2 groups of patients, of 25 individuals each, whi undergo medial unicompartmental knee arthroplasty.
The first group will be operated with a robot-assisted technique (with CORI Surgical System, Smith and Nephew, USA), the other with standard technique and the same implant (Journey UNI II, Smith and Nephew, USA).
The study will be a randomized and controlled blind superiority trial. Patients will not be informed about performing the surgery with one technique or the other in order to avoid potential biases in the data analysis.
Patients will be recruited at the orthoaedic and traumatologic 2nd clinica (head prof S. Zaffagnini) at IRCSS Istituto Ortopedico Rizzoli in Bologna, Italy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two blinded groups operated via robotic-assisted surgery (1st arm) or conventional technique (2nd arm).
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted UKA | Experimental | Procedure: Robot-assisted UKAUnicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via CORI surgical system (Smith \& Nephew, USA). |
| Standard technique UKA | Active comparator | Procedure: Standard technique UKAUnicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via standard technique. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unicompartmental Knee Arthrosis
- Femoral condyles or medial tibial plate osteonecrosis
- Healthy anterior cruciate ligament, posterior cruciate ligament and collateral ligaments of the affected knee
- Post traumatic loss of joint configuration
- Moderate varism deformity
Key exclusion criteria (6 listed)
- Bi or Tricompartmental arthrosis
- Unhealty anterior or posterior cruciate ligaments or collateral ligaments
- Patients with neuromuscolar, degenerative and joint-related conditions
- Patients younger than 50
- Patients older than 80
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 |
|---|---|---|
| Robot-assisted UKAAlso: CORI Surgical System, Smith and NephewCemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients. | Procedure or surgery | Robot-assisted UKA |
| Standard technique UKACemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients. | Procedure or surgery | Standard technique UKA |
Primary outcome
Static radiostereometric analysis (RSA)
Time frame: Within 7 days from surgery, during hospitalisation
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Static radiostereometric analysis (RSA)
Time frame: 3 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Static radiostereometric analysis (RSA)
Time frame: 6 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Static radiostereometric analysis (RSA)
Time frame: 12 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
Static radiostereometric analysis (RSA)
Time frame: 24 months
Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison
7 secondary outcomes
Gait analysis via inertial sensors
Time frame: Within 7 days from surgery, during hospitalisation
Gait analysis via inertial sensors
Time frame: 6 months
Gait analysis via inertial sensors
Time frame: 24 months
American Knee Society score
Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Oxford Knee Score
Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Patient Satisfaction Score
Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
EQ5-D questionnaire
Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
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 23 Jan 2026.
- Individual participant dataSharing planned: No. No sharing planned
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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.
Stefano Zaffagnini, Prof. principal investigator
IRCCS Istituto Ortopedico Rizzoli
Giulio Maria Marcheggiani Muccioli, Prof. study director
IRCCS Istituto Ortopedico Rizzoli
Stefano Fratini, Dr. study chair
IRCCS Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted UKA and Standard technique UKA in people with Loosening, Prosthesis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. 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 Italy. 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?
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?
Static radiostereometric analysis (RSA) (time frame: Within 7 days from surgery, during hospitalisation). 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?
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 23 Jan 2026.