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Uncemented Tritanium TKR vs Cemented Triathlon TKR

NCT04040764 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-12

No results posted yet for this study

Summary

The Study aims to investigate whether there is a clinically important difference in peri-articular bone mineral density (BMD) and trabecular bone score (TBS) between patients undergoing two different types of knee replacement fixation - uncemented Tritanium total knee replacement (TKR) and cemented Triathlon TKR.

Before undertaking a full randomised control trial however, it is necessary to establish that the proposed methodology and approach are feasible. Therefore an internal pilot study will be performed first. This registration is for the internal pilot study.

Conditions

Interventions

PROCEDURE

Tritanium uncemented Total Knee Replacement

This will be an internal pilot study in which patients will be blinded and randomly assigned to 1 of 2 arms with 30 patients in each arm. The first arm will receive a Triathlon knee replacement device which is cemented into place. The second arm will receive an uncemented Triathlon Tritanium TKR.

Sponsors & Collaborators

  • University of Exeter

    collaborator OTHER

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ben Waterson, MD · Royal Devon and Exeter NHS Foundation Trust Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2025-12-01
Completion
2026-06-30

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 NCT04040764 on ClinicalTrials.gov