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Bespoke vs Standard Instrumentation in TKR

NCT02845206 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-09-23

No results posted yet for this study

Summary

Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. The pain and function after TKR can be dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated failure. Patient specific cutting blocks may result in a more individualised implant placement, improved pain and function following surgery, and a long-lasting implant.

This trial is designed to investigate if there is any benefit to bespoke instrumentation in terms of pain and function to the patient, and an economic benefit to the NHS.

Conditions

Interventions

PROCEDURE

Patient specific cutting blocks

'MyKnee' Instrumentation

PROCEDURE

Conventional cutting blocks

Standard Instrumentation

Sponsors & Collaborators

  • NHS Lothian

    lead OTHER_GOV

Principal Investigators

  • Leela C Biant, FRCSEd(Tr&Orth) MSres MFSTEd · University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2018-02-02
Completion
2020-02-02

Countries

  • United Kingdom

Study Locations

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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 NCT02845206 on ClinicalTrials.gov