NCT01307384

Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study

Prospective Post Market Clinical Follow-Up Study of the Continuum Metal on Polyethylene Acetabular System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 165 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.

Detailed description

The safety and performance of the Continuum Metal on Polyethylene Acetabular System will be confirmed by the assessment of survival and outcome data. Assessments will include standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility, and survivorship of the Continuum Metal on Polyethylene Acetabular system in primary total hip arthroplasty. Metal ion (cobalt, chromium and titanium) and renal function (BUN, Creatinine and GFR) levels will be analyzed for a subset of the enrolled study subjects.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Continuum Metal on Polyethylene Acetabular System	Used in primary hip arthroplasty

Timeline

• Start date: 2011-03-29
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2011-03-02
• Last updated: 2025-06-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study