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Active, not recruitingNCT05204797Updated Jan 23, 2026

Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After UKA

An interventional study of Robot-assisted UKA and Standard technique UKA in Loosening, Prosthesis, sponsored by Istituto Ortopedico Rizzoli. Active, not recruiting at 1 site in Italy. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Loosening, Prosthesis

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03

In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's planned enrollment of 50 is above the median of 36 across 69 interventional studies indexed under Prosthesis Failure.

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Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.

Browse Istituto Ortopedico Rizzoli studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Robot-assisted UKA

    Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via CORI surgical system (Smith \& Nephew, USA).

    Procedure: Robot-assisted UKA

  • Active comparator
    Standard technique UKA

    Unicompartmental knee replacement (Journey II UKA, Smith and Nephew, USA) positioned via standard technique.

    Procedure: Standard technique UKA

Interventions

  • ProcedureRobot-assisted UKA

    Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients.

    Also known as: CORI Surgical System, Smith and Nephew

  • ProcedureStandard technique UKA

    Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients.

06

What researchers measure

Primary outcomes

  1. Static radiostereometric analysis (RSA)

    Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

    Time frame: Within 7 days from surgery, during hospitalisation

  2. Static radiostereometric analysis (RSA)

    Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

    Time frame: 3 months

  3. Static radiostereometric analysis (RSA)

    Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

    Time frame: 6 months

  4. Static radiostereometric analysis (RSA)

    Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

    Time frame: 12 months

  5. Static radiostereometric analysis (RSA)

    Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison

    Time frame: 24 months

Secondary outcomes

  1. 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.

    Time frame: Within 7 days from surgery, during hospitalisation

  2. 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.

    Time frame: 6 months

  3. 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.

    Time frame: 24 months

  4. American Knee Society score

    Used to test knee function by the investigator: it has a clinical and a functional part

    Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up

  5. Oxford Knee Score

    Consists of 12 questions to be filled by the patient to assess how the prosthesis affect activities of daily living.

    Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up

  6. Patient Satisfaction Score

    A short personal questionnaire that assesses subjective satisfaction after surgery

    Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up

  7. 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.

    Time frame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — No sharing planned

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2021 (actual). Primary completion is estimated for Dec 2027, 74 months after the start.

Of 48 non-industry interventional studies with no phase under Prosthesis Failure, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 74 months is above that.

Counting every sponsor, half of 50 studies reached it within 18 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2021
First posted
Jan 24, 2022
StartActual
Oct 7, 2021
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Jan 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05204797
Lead sponsor
Istituto Ortopedico Rizzoli
Collaborators
Smith & Nephew, Inc.
Responsible party
Stefano Zaffagnini (Head of Orthopaedics and Traumatology II Clinic, Istituto Ortopedico Rizzoli) — Principal investigator
First posted
Jan 24, 2022
Start date
Oct 7, 2021
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jan 23, 2026

Study contacts

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
Stefano Di Paolo, Eng.
study chair · University of Bologna
Laura Bragonzoni, Dr.
study chair · University of Bologna
Raffaele Zinno, Dr.
study chair · University of Bologna
Giuseppe Barone, Dr.
study chair · University of Bologna

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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