Clinical trial NCT05204797: Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After UKA
Official title: Efficacy of Robot-assisted Technique vs Conventional Technique in Preventing Early Micromobilisation After Unicompartmental Knee Arthroplasty: a Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Loosening, Prosthesis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2022-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two blinded groups operated via robotic-assisted surgery (1st arm) or conventional technique (2nd arm).
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Static radiostereometric analysis (RSA)
timeFrame: Within 7 days from surgery, during hospitalisation
measure: Static radiostereometric analysis (RSA)
timeFrame: 3 months
measure: Static radiostereometric analysis (RSA)
timeFrame: 6 months
measure: Static radiostereometric analysis (RSA)
timeFrame: 12 months
measure: Static radiostereometric analysis (RSA)
timeFrame: 24 months
Secondary outcomes:
measure: Gait analysis via inertial sensors
timeFrame: Within 7 days from surgery, during hospitalisation
measure: Gait analysis via inertial sensors
timeFrame: 6 months
measure: Gait analysis via inertial sensors
timeFrame: 24 months
measure: American Knee Society score
timeFrame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
measure: Oxford Knee Score
timeFrame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
measure: Patient Satisfaction Score
timeFrame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
measure: EQ5-D questionnaire
timeFrame: Pre-operatively, then at 3, 6, 12 and 24 months follow-up
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
state: Emilia Romagna
Study officials:
affiliation: IRCCS Istituto Ortopedico Rizzoli
name: Stefano Zaffagnini, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Istituto Ortopedico Rizzoli
name: Giulio Maria Marcheggiani Muccioli, Prof.
role: STUDY_DIRECTOR
affiliation: IRCCS Istituto Ortopedico Rizzoli
name: Stefano Fratini, Dr.
role: STUDY_CHAIR
affiliation: University of Bologna
name: Stefano Di Paolo, Eng.
role: STUDY_CHAIR
affiliation: University of Bologna
name: Laura Bragonzoni, Dr.
role: STUDY_CHAIR
affiliation: University of Bologna
name: Raffaele Zinno, Dr.
role: STUDY_CHAIR
affiliation: University of Bologna
name: Giuseppe Barone, Dr.
role: STUDY_CHAIR
References: