Robotic-assisted Total Knee Arthroplasty vs. Conventional One

NCT04611815 | Completed

• 1 other identifier: WarsawMU/RATKA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares and evaluates differences in movement analysis, patient-reported outcome and radiological assesment between patients undergoing robotic-assisted total knee arthroplasty and conventional one.

Conditions

Osteo Arthritis Knee; Knee Arthritis; Knee Pain Chronic

Outcome Measures

Primary Outcomes (6)

• Changes in patients reported outcome measures - Oxford Knee Score (OKS)

  To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 48, with higher scores corresponding to better outcomes.

  At baseline (preoperatively), 6-8 weeks and 12 months postoperatively.

• Changes in patients reported outcome measures - Knee injury and Osteoarthritis Outcome Score (KOOS)

  To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.

  At baseline, 6-8 weeks post-operatively and 12 months post-operatively.

• Changes in patients reported outcome measures - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 96, with lower scores corresponding to better outcomes.

  At baseline, 6-8 weeks post-operatively and 12 months post-operatively.

• Changes in patients reported outcome measures - Lysholm knee scoring scale

  To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.

  At baseline, 6-8 weeks post-operatively and 12 months post-operatively.

• Changes in patients range of motion (ROM)

  To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.

  At baseline, 6-8 weeks post-operatively and 12 months post-operatively.

• *We take into consideration the possible use of other PROM questionnaires and analysis of different adverse events depending on the unpredictable circumstances.

  To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.

  At baseline, 6-8 weeks post-operatively and 12 months post-operatively.

Secondary Outcomes (17)

• Changes in patients reported outcome measures - Oxford Knee Score (OKS)

  [Time Frame: 1 week and 6-8 weeks post-operatively]

• Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ)

  Time Frame: 1 week, 6-8 weeks and 6 months post- operatively

• Changes in patients reported outcomes - Forgotten Joint Score (FJS)

  Time Frame: 6-8 weeks and 6 months post-operatively

• Changes in patients reported outcomes - UCLA (University of California) score

  Time Frame: 6-8 weeks and 12 months post-operatively

• Changes in knee range of motion

  Time Frame: preoperatively, 6-8 weeks and 12 months post-operatively

Study Arms (2)

Robotic-assisted total knee arthroplasty

ACTIVE COMPARATOR

Patients undergoing robotic-assisted total knee arthroplasty with use of Journey II BCS implants

Procedure: Total knee arthroplasty; Diagnostic Test: Computer tomography scan; Diagnostic Test: biomechanical assesment

Conventional total knee arthroplasty

ACTIVE COMPARATOR

Patients undergoing conventional total knee arthroplasty with use of Journey II BCS implants

Procedure: Total knee arthroplasty; Diagnostic Test: Computer tomography scan; Diagnostic Test: biomechanical assesment

Interventions

Total knee arthroplasty PROCEDURE

Participant will undergo robotic-assisted or conventional total knee arthroplasty

Conventional total knee arthroplasty; Robotic-assisted total knee arthroplasty

Computer tomography scan DIAGNOSTIC_TEST

CT scans of the affected knee joint before and after the surgical procedure

Conventional total knee arthroplasty; Robotic-assisted total knee arthroplasty

biomechanical assesment DIAGNOSTIC_TEST

Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively

Conventional total knee arthroplasty; Robotic-assisted total knee arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Listed for a primary total knee replacement (TKR)
• Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
• Aged 18 or over
• Patient willing to provide full informed consent to the trial

You may not qualify if:

• Listed for a single-stage one-sided TKR procedure
• Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
• Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
• Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
• Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
• Inflammatory arthritis
• Previous septic arthritis in the affected knee joint
• Previous surgery to the collateral ligaments of the affected knee
• A contralateral total knee replacement that has been implanted less than one year from the date of consultation
• A contralateral total knee replacement that is severely painful
• Patients on warfarin or novel oral anticoagulants (NOACs)
• Will not be resident in the catchment area for at least 6 months post-surgery
• Undertaking the surgery as a private patient
• Patients who, in the opinion of the clinical staff, do not have capacity to consent
• Patients who are pregnant

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 04-749, Poland

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Bartosz M. Maciąg, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant will not be informed whether theis surgery was performed with robotics assist. Outcomes Assessor, Care provider, Investigator will not be informed which type of prosthesis was used in particular patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: August 1, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

PL (1)