Loosening, Prosthesis
Conditions
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.
Interventions
PROCEDURERobot-assisted UKA
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and robotic assistance. Tourniquet will be used in all patients.
PROCEDUREStandard technique UKA
Cemented unicompartmental knee arthroplasty via mini-invasive medial approach and standard technique. Tourniquet will be used in all patients.
Sponsors
Istituto Ortopedico Rizzoli
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
At the research office of health professions at IRCCS Istituto Ortopedico Rizzoli in Bologna, Italy (coordinating centre), a block of 5 randomisation list using the site "www.randomisation.com" will be generated. A sequence of opaque envelopes will be set up with a sequential number on the outside. A label will be placed iside the envelope that will contain the words "CORI" or "STANDARD", according to the sequence indicated by the generated list. Envelopes will be always sealed at the Research Centre and the list kept under lock. The envelopes will be placed in a dedicated box and delivered to the studio manager.
Intervention model description
Two blinded groups operated via robotic-assisted surgery (1st arm) or conventional technique (2nd arm).
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static radiostereometric analysis (RSA) | Within 7 days from surgery, during hospitalisation | Dual X-Ray simultaneous evaluation of micromobilisation via radiopaque markers and software comparison |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Knee Society score | Pre-operatively, then at 3, 6, 12 and 24 months follow-up | Used to test knee function by the investigator: it has a clinical and a functional part |
| Oxford Knee Score | Pre-operatively, then at 3, 6, 12 and 24 months follow-up | Consists of 12 questions to be filled by the patient to assess how the prosthesis affect activities of daily living. |
| Patient Satisfaction Score | Pre-operatively, then at 3, 6, 12 and 24 months follow-up | A short personal questionnaire that assesses subjective satisfaction after surgery |
| EQ5-D questionnaire | Pre-operatively, then at 3, 6, 12 and 24 months follow-up | a questionnaire filled by the patient assessing the overall health of the subject. It is a test used to assess quality of life index. |
| Gait analysis via inertial sensors | Within 7 days from surgery, during hospitalisation | Inertial sensors (Awinda, Xsens Technologies and Gwalk, BTS engineering) will be placed on the patients then performed walking under VICON cameras analysis. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORStefano Zaffagnini, Prof.
IRCCS Istituto Ortopedico Rizzoli
STUDY_DIRECTORGiulio Maria Marcheggiani Muccioli, Prof.
IRCCS Istituto Ortopedico Rizzoli
STUDY_CHAIRStefano Fratini, Dr.
IRCCS Istituto Ortopedico Rizzoli
STUDY_CHAIRStefano Di Paolo, Eng.
University of Bologna
STUDY_CHAIRLaura Bragonzoni, Dr.
University of Bologna
STUDY_CHAIRRaffaele Zinno, Dr.
University of Bologna
STUDY_CHAIRGiuseppe Barone, Dr.
University of Bologna
Outcome results
None listed