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Bespoke vs Standard Instrumentation in TKR

NCT05579951 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-01-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Manchester

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Leela Biant · University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579951 on ClinicalTrials.gov