MedTrace Logo

Early Stability of the Delta-TT Cup With Polyethylene Insert Versus a Ceramic Insert. A RSA Study.

NCT03093038 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-10-13

No results posted yet for this study

Summary

The goal of this study is to study the stability of the Delta-TT cup with polyethylene insert and the Delta-TT cup with ceramic insert both combined with the H-MAX femoral stem by means of RSA to assess whether the differences in stiffness of the cup will have an influence on incorporation and mechanical stability.

It is hypothesized that there will be more micromotion on the short-term (\<2 years) in the patients with the ceramic insert because of the higher stiffness, however, all components will be considered stable on the short and long-term.

Conditions

  • Osteoarthrosis

Interventions

DEVICE

H-MAX stem & Delta-TT cup + polyethylene

H-MAX femoral stem \& Delta-TT cup with a polyethylene insert

DEVICE

H-MAX stem & Delta-TT cup + ceramic

H-MAX femoral stem \& Delta Delta-TT cup with a Ceramic insert

DEVICE

C2 stem & Delta-TT cup + ceramic

C2 femoral stem Delta Delta-TT cup with a Ceramic insert

Sponsors & Collaborators

  • JointResearch

    lead OTHER

Principal Investigators

  • Rudolf W Poolman, MD PhD · Onze Lieve Vrouwe Gasthuis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-02-28
Completion
2021-05-31

Countries

  • Netherlands

Study Locations

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 NCT03093038 on ClinicalTrials.gov