Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation

Summary

The goal of this clinical trial is to learn whether robotic-assisted total knee replacement improves recovery compared with conventional total knee replacement in adults with knee osteoarthritis when both groups follow the same structured home-based rehabilitation program. Robotic-assisted and conventional (non-robotic) total knee replacement are both widely used as part of routine clinical care. This study will compare recovery during the first six weeks after surgery.

The main questions the study aims to answer are:

1. Does robotic-assisted total knee replacement improve knee pain and knee function six weeks after surgery compared with conventional total knee replacement?
2. Does robotic-assisted surgery improve physical function, walking ability, leg strength, quality of life, and participants' experience of rehabilitation?
3. Are there any differences in recovery, length of hospital stay, or safety between the two surgical approaches?

Researchers will compare robotic-assisted total knee replacement with conventional total knee replacement. Both groups will complete the same rehabilitation program before and after surgery so that any differences in recovery are more likely to be related to the type of surgery rather than differences in rehabilitation.

Participants will:

* Be randomly assigned (by chance, similar to flipping a coin) to receive either robotic-assisted or conventional total knee replacement surgery.
* Complete a structured rehabilitation program that includes education and exercises during the four weeks before surgery and a home-based exercise program for six weeks after surgery.
* Use a study-provided seated exercise bike, receive support from a physiotherapist through telehealth appointments, secure messaging, and home visits where required, and use a digital application to guide the rehabilitation program and record exercise completion and symptoms.
* Complete questionnaires about knee pain, knee function, general health, quality of life, and satisfaction with the rehabilitation program.
* Attend study assessments before surgery, immediately before surgery after completing the pre-surgery program, and about six weeks after surgery. These assessments include simple physical activities such as standing up from a chair, walking, cycling, and measuring leg strength.
* Allow information about their surgery and hospital stay, such as the duration of surgery and the number of nights spent in hospital, to be recorded for the study.

The results of this study will help researchers understand whether robotic-assisted total knee replacement provides additional benefits over conventional total knee replacement when both are combined with the same structured home-based rehabilitation program. The findings may help patients, healthcare professionals, and health services make informed decisions about the use of robotic-assisted knee replacement surgery.

Conditions

• Osteoarthritis, Knee

Interventions

PROCEDURE

Robotic-assisted Total Knee Arthroplasty

Primary total knee arthroplasty performed using an approved robotic-assisted surgical system by an experienced orthopaedic surgeon. Robotic assistance is used for pre-operative planning and/or intra-operative execution of bone resections and component positioning in accordance with the manufacturer's instructions for use and the surgeon's standard clinical practice.

PROCEDURE

Conventional Total Knee Arthroplasty

Primary total knee arthroplasty performed using conventional manual instrumentation without robotic assistance by an experienced orthopaedic surgeon. Surgical technique follows standard clinical practice.

BEHAVIORAL

Hybrid Virtually-Assisted Peri-operative Rehabilitation Program

A standardized hybrid virtually-assisted comprehensive peri-operative care program delivered before and after surgery. The program comprises a 4-week pre-operative preparation phase followed by a 6-week post-operative rehabilitation phase. It includes patient education, home-based cycling and non-cycling exercises, telehealth consultations, tele-messaging support, remote monitoring, limited in-person physiotherapy services, and symptom-contingent, rule-based exercise progression. The program is delivered identically to both study groups using standardized, protocol-defined procedures.

Sponsors & Collaborators

• Curtin University

  collaborator OTHER

• Johnson & Johnson Medical Companies

  collaborator INDUSTRY

• Mark Hurworth

  lead INDUSTRY

Principal Investigators

• Mark Hurworth, MBChB FRACS FA(Orth)A · Murdoch Orthopaedic Clinic, St John of God Medical Centre, 10/100 Murdoch Drive, Murdoch 6150 WA, Australia

• Novak S. J. Elliott, MBiomedE PhD · Curtin School of Allied Health, Curtin University, Kent Street, Bentley WA 6102, Australia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2028-12-31

Completion

2028-12-31