Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation | NCT07716267

NCT07716267

Overview

NCT ID: NCT07716267
Lead Sponsor: Mark HurworthINDUSTRY
Official Title: Evaluation Of Robotic-Assisted Versus Conventional Total Knee Arthroplasty Within A Virtual Peri-Operative Comprehensive Care Program: A Protocol For A Randomized Controlled Trial Assessing Knee-related Pain and Functional Limitation
Brief 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:

Does robotic-assisted total knee replacement improve knee pain and knee function six weeks after surgery compared with conventional total knee replacement?

Does robotic-assisted surgery improve physical function, walking ability, leg strength, quality of life, and participants' experience of rehabilitation?

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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Dec 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Adults aged 40 years or older.

Knee osteoarthritis confirmed by clinical assessment and imaging (e.g., X-ray or MRI) requiring primary total knee replacement surgery.

Scheduled to undergo primary total knee arthroplasty with one of the participating surgeons at St John of God Murdoch Hospital.

Able to understand the study requirements and provide written informed consent.

Physically able to participate in the home-based exercise and stationary cycling rehabilitation program.

Exclusion Criteria:

Unable to understand English sufficiently to provide informed consent, complete study questionnaires, or safely follow the rehabilitation program.

Previous major surgery on the leg undergoing knee replacement (for example, revision knee replacement or high tibial osteotomy).

Osteoarthritis caused by another medical condition (for example, inflammatory arthritis, previous joint infection, gout, fracture involving the joint, congenital abnormality, or haemochromatosis).

Chronic pain unrelated to the knee being replaced that could affect study assessments.

Unstable heart or lung conditions that make exercise-based rehabilitation unsafe.

Body weight greater than 120 kg.

Physical conditions that prevent safe participation in the cycling-based rehabilitation program or completion of the study assessments.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Novak S. J. Elliott, MBiomedE PhDContact
n.s.j.elliott@curtin.edu.au

Similar Studies

Participant Group/Arms

Robotic-assisted Total Knee ArthroplastyExperimental

Participants undergo robotic-assisted primary total knee arthroplasty and receive a standardized hybrid virtually-assisted comprehensive peri-operative care program comprising a 4-week pre-operative preparation phase and a 6-week post-operative rehabilitation phase, including patient education, home-based exercise, telehealth support, tele-messaging, remote monitoring, and limited in-person physiotherapy services.

Procedure: Robotic-assisted Total Knee Arthroplasty

Behavioral: Hybrid Virtually-Assisted Peri-operative Rehabilitation Program

Conventional Total Knee ArthroplastyActive Comparator

Participants undergo conventional (non-robotic) primary total knee arthroplasty and receive the same standardized hybrid virtually-assisted comprehensive peri-operative care program comprising a 4-week pre-operative preparation phase and a 6-week post-operative rehabilitation phase, including patient education, home-based exercise, telehealth support, tele-messaging, remote monitoring, and limited in-person physiotherapy services.

Procedure: Conventional Total Knee Arthroplasty