MedTrace Logo

Cemented Versus Cementless Unicompartmental Knee Arthroplasty

NCT05935878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-09-23

Study results available
· View outcomes & findings →

Summary

Unicompartmental knee replacement for selected cases of osteoarthritis is less invasive than total knee replacement. It gives better range of movement; patients stay for shorter time in the hospital and have a more natural feel than total knee replacement. Usually, the implant is fixed in the bone using bone cement. However, there are potential disadvantages of using bone cement. The operation takes longer; cement can get squeezed out into the surrounding tissues and may interfere with function. To avoid these problems, the implant can be fixed without cement. Cementless components have a special coating to encourage bone in-growth and fixation. Although the investigators believe cementless fixation will be at least as good as cemented fixation, there is a risk that it could be worse and might result in loosening.

The aim of this study is therefore to compare the outcome of cemented and cementless unicompartmental knee replacement.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Cementless Oxford Unicompartmental Knee Arthroplasty

All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth. The cementless femoral component also has a smaller second peg, located anteriorly to the larger central peg that is also present of the cemented femoral component.

DEVICE

Cemented Oxford Unicompartmental Knee Arthroplasty

All patients will undergo the same surgical approach. 0.8mm diameter tantalum marker balls will be placed in the tibia and femur in all cases. All cemented components will be secured using the same cement.

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • David W Murray, MA, MD, FRCS · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-08
Primary Completion
2022-03-11
Completion
2022-03-11
FDA Device
Yes

More Related Trials

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 NCT05935878 on ClinicalTrials.gov