Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement

NCT04378049 | Active Not Recruiting

• 1 other identifier: RoboKnees
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot randomized trial to assess the feasibility of a definitive trial to determine the effect of robot-assisted partial knee replacements versus standard total knee replacements.

Conditions

Knee Osteoarthritis

Keywords

Total knee arthroplasty; Unicompartmental knee arthroplasty; Robot-assisted surgery; Pilot randomized controlled trial; Bicompartmental knee arthroplasty; Mako partial knee

Outcome Measures

Primary Outcomes (3)

• Feasibility- Recruitment

  The number of patients recruited during a 12 month period

  12 months

• Feasibility- Participant retention

  Number of patients completing the study

  12 months

• Feasibility- Treatment compliance

  The number of crossovers during a 12 month period

  12 months

Secondary Outcomes (12)

• Return to function questionnaire

  12 months post-surgery

• Oxford knee score

  12 months post-surgery

• Forgotten joint score

  12 months post-surgery

• Gait walking mechanics analysis

  12 months post-surgery

• Quality of life- EQ-5D

  12 months post-surgery

Study Arms (2)

Standard total knee arthroplasty

ACTIVE COMPARATOR

Participants who are randomized to the control group will undergo TKA according to local standard of care. The choice of implant and use of bone cement will be recorded but left to the surgeon's discretion according to their standard practice.

Procedure: Total knee arthroplasty

Robot-assisted partial knee arthroplasty

EXPERIMENTAL

Participants with isolated medial or isolated lateral compartment OA who are randomized to the intervention group and have one affected knee compartment will receive a robot-assisted unicompartmental knee arthroplasty (UKA). If the patient has medial or lateral OA plus patellofemoral OA they will receive a bicompartmental knee arthroplasty (BiKA) consisting of a two simultaneous UKAs. The partial knee replacement procedures will be performed using the Mako RIO robotic arm (Stryker) according to the manufacturer's instructions. The choice of implant and use of bone cement will be recorded but will be left to the surgeon's discretion. Surgeons will resurface the patella if the patellar cartilage meets Outerbridge grade 3 or 4 criteria

Procedure: Robot-assisted partial knee arthroplasty

Interventions

Total knee arthroplasty PROCEDURE

Surgeon will perform a total knee arthroplasty procedure according to local standard of care

Also known as: Total knee replacement

Standard total knee arthroplasty

Robot-assisted partial knee arthroplasty PROCEDURE

Surgeon will perform a robot-assisted unicompartmental or bicompartmental knee arthroplasty procedure

Also known as: MakoPlasty

Robot-assisted partial knee arthroplasty

Eligibility Criteria

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

You may qualify if:

• Adult (18+)
• Unicompartmental knee OA with or without concomitant patellofemoral OA, requiring surgical treatment
• Two study surgeons independently agree that the patient is eligible for either treatment group

You may not qualify if:

• Inability to provide informed consent (e.g. cognitive disability, language barrier)
• Revision knee surgery
• Simultaneous bilateral knee surgery
• Previous major knee surgery or trauma
• The robot or required components are unavailable (e.g. technical difficulties, robot-specific disposables out of stock)
• A CT scan cannot be obtained prior to surgery
• Patient does not wish to participate

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator
• Hamilton Academic Health Sciences Organization: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• Madden K, Flood B, Malek M, Milantoni V, Astephen Wilson JL, Tarride JE, Khanna V, Adili A; RoboKnees Investigators. Robot-assisted partial knee replacement versus standard total knee replacement (RoboKnees): a protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2024 Feb 21;10(1):39. doi: 10.1186/s40814-024-01463-x.

  PMID: 38383530 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Anthony Adili, MD, P.Eng, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Surgeons cannot be blinded to treatment group. It would not be feasible to blind the health care team and patients because the incisions and imaging are visually distinguishable. We will attempt to minimize bias in subjective measures by presenting patients with balanced information on each treatment group prior to the trial. All participants will receive a computed tomography (CT) scan prior to surgery to maintain blinding and to give surgeons additional information about 3 dimensional modelling for implant placement. Data analysts will be blinded to treatment allocation. An independent outcomes assessor will independently review radiographic alignment for each patient and review relatedness of adverse events and re-operations. The independent assessor cannot be blinded because imaging is visually distinguishable.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: November 23, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon study completion.

Locations

CA (1)