NCT03343171

Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 203 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to obtain implant survivorship and clinical outcome data for the commercially available Zimmer® Continuum™ Ceramic-on-Ceramic Bearing System when used in primary hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and efficacy of the Continuum Ceramic-on-Ceramic Bearing System.

Detailed description

The subject of this clinical investigation is the Continuum Ceramic Bearing THA System in primary total hip arthroplasty. This system consists of a cementless modular Trabecular Metal™ (TM) Continuum Acetabular Shell, a modular BIOLOX delta Taper liner, and a modular BIOLOX delta 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. The study design will be a prospective, multicenter, non-comparative post-market study, involving orthopedic surgeons skilled in hip arthroplasty procedures. A total of 200 patients will be enrolled into the study distributed between 6 study centres. This number of clinical centers will permit assessment of consistency among a multitude of investigators. Follow-up visits will. be performed at 6 weeks, 6 months, 1,2, 3, 5; 7 and 10 years post-operatively. All potential study subjects will be required to participate in the Informed Consent Process. The safety and performance of the Implant System will be assessed as following: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and Performance will be determined by comparing the overall pain and functional performances, survivorship, subject quality-of-life and radiographic parameters of study subjects who received the Continuum Ceramic Bearing System.

Conditions

• Osteoarthritis
• Avascular Necrosis
• Inflammatory Arthritis
• Post-traumatic Arthritis

Timeline

• Start date: 2010-09-15
• Primary completion: 2025-02-01
• Completion: 2025-09-01
• First posted: 2017-11-17
• Last updated: 2025-01-31

Locations

6 sites across 3 countries: Finland, Italy, United Kingdom