NCT05842538

Robotic Assisted Surgery In Total Knee Replacement

Robotic Assisted Surgery In Total Knee Replacement Versus Manual Total Knee Arthroplasty: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare robotic arm assisted surgery with manual surgery in patients operated with knee replacement. The main aim of the study is to compare changes in joint awareness (measured by the Forgotten Joint Score. Participants who are listed for knee arthroplasty are randomised to either robotic arm assisted surgery or manual surgery.

Detailed description

Study Title: Robotic Assisted Surgery in total knee replacement versus Manual Total Knee Arthroplasty: A randomised controlled trial Type of study: CE marked device study Trial Design: Multi-center site prospective parallel group randomised controlled trial Trial Participants: Listed for routine primary total knee replacements Investigational Device: MAKO Robotic Arm Assisted Surgical System Control: Conventional jig-based surgery Implant (Intervention and Control): Triathlon TKR Planned Sample Size: 200 (100 MAKO, 100 Manual) Follow-up duration: 24 months following surgery Planned Trial Period: Nov 2022 - 2024 Primary Objective: To compare changes in joint awareness (measured by the Forgotten Joint Score (FJS)20) from baseline to 12 months following TKR between the two groups. Secondary Objectives 1. To compare pain measured using the pain visual analogue scale. 2. To compare the health-related quality of life using the EQ5D-3L at baseline, 3, 12 and 24 months. 3. To compare changes in knee function in activities of daily living (measured by the Oxford knee score (OKS)19) from baseline to 3, 12 and 24 months. 4. To compare changes in clinically assessed pain and stiffness (measured by the Knee Society Score (KSS)) at baseline to 3 and 12 months. 5. To compare revision rate using implant migration measured by CTMA at 12 and 24 months as a surrogate marker for revision. Primary Endpoint: Functional outcome measured by the changes in joint awareness of the FJS score at 12 months following the intervention. Secondary Endpoints: Secondary outcomes will be collected up to 24 months following the intervention. Device Name: Both arms will receive Triathlon TKR with a highly crossed linked (X3) cruciate retaining polyethylene insert. The intervention group will utilise the MAKO robotic arm to make the bone cuts.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Triathlon	Total knee arthroplasty

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-11-01
• Completion: 2027-11-01
• First posted: 2023-05-06
• Last updated: 2023-10-10

Locations

2 sites across 1 country: Sweden