NCT03093038

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

Early Stability of the Delta-TT Cup With Polyethylene Insert Compared to the Delta-TT Cup With Ceramic Insert. A Randomised RSA Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: JointResearch · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Rationale: Roentgen Stereophotogrammetric Analysis (RSA) is a very accurate measurement technique used to obtain micromotion of the implants relative to inserted tantalum markers in the surrounding bone. Using RSA, long-term predictions of prosthetic loosening can be made based on a two years follow-up. Therefore, it is recommended to analyse all (new) prosthetic components by means of RSA. Objective: The goal of this study is to study in a randomised trial 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. Secondary goal is to compare the stability of the C2 femoral stem, to the H-MAX femoral stem as well as to compare it to relevant migration results of similar stems from the literature. These RSA results will contribute to knowledge about the early stability and long-term prosthetic loosening of these cementless stems.

Conditions

• Osteoarthrosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-02-01
• Completion: 2021-05-01
• First posted: 2017-03-28
• Last updated: 2021-10-13

Locations

1 site across 1 country: Netherlands