NCT05579951

Bespoke vs Standard Instrumentation in TKR

Randomised Control Trial of Patient Specific Instrumentation vs Standard Instrumentation of the GMK-Sphere (Global Medacta Knee) Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Total knee replacements are operations that are offered to patients who have severe arthritis pain that is affecting daily activities that is no longer controlled with painkillers. The operation will replace the worn joints with metal implants and a plastic spacer. Total knee replacements are successful operations in the vast majority of patients. However, a small minority of patients are not entirely satisfied with the outcome of their knee replacement. Researchers are studying whether the precise positioning of the implant has an effect on the outcome. This study will look at whether patient-specific instrumentation improves implant position and if it leads to improved patient function so that we know what to recommend in the future.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Patient specific instrumentation	Total knee replacement with patient specific instrumentation
PROCEDURE	Conventional	Total knee replacement with conventional instrumentation
DEVICE	Patient specific instrumentation	Medacta GMK Sphere MyKnee Patient specific Instrumentation

Timeline

• Start date: 2021-09-21
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-10-14
• Last updated: 2025-01-29

Locations

1 site across 1 country: United Kingdom