Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT05579951
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bespoke vs Standard Instrumentation in TKR
Sponsor:
Manchester University NHS Foundation Trust
Organization:
Study Overview
Official Title:
Randomised Control Trial of Patient Specific Instrumentation vs Standard Instrumentation of the GMK-Sphere (Global Medacta Knee) Total Knee Arthroplasty
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPHERE
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: