NCT03382652

Continuum™ Metal Bearing System in Total Hip Arthroplasty

Continuum™ Metal Bearing System in Total Hip Arthroplasty- A Multi-center, Prospective, Non-controlled Post Market Surveillance Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and outcome data on the Continuum Metal Bearing System in primary total hip arthroplasty.

Detailed description

The subject of this clinical investigation is the Continuum Metal Bearing THA System in primary total hip arthroplasty. This system consists of a cementless modular Trabecular Metal® (TM) Continuum Acetabular Shell, a modular Metasul Taper liner, and a modular Metasul femoral head. The characteristics of this THA system may allow for reduction in wear and osteolysis as compared to other approved and marketed THA systems and thus increase the expected implant life. In total, 3 sites were involved. This number of clinical sites permitted assessment of the consistency among a multitude of investigators. A total number of 83 were included in the study.

Conditions

• Avascular Necrosis
• Osteoarthritis
• Inflammatory Arthritis
• Post-traumatic; Arthrosis
• Total Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	Metal-on-Metal Articulation	\<Metal-on-Metal Articulation\>: Metasul® Taper Liner and Metasul Femoral Head, \<Acetabular Component\>:Continuum Acetabular Shell, \<Femoral Component\>: Zimmer® M/L Taper Hip Stem

Timeline

• Start date: 2011-02-09
• Primary completion: 2022-10-22
• Completion: 2022-10-22
• First posted: 2017-12-26
• Last updated: 2025-01-03
• Results posted: 2024-12-16

Locations

3 sites across 2 countries: United States, Finland

Regulatory

• FDA-regulated device study