Total Hip Arthroplasty for Arthritis

N/A

Waitlist Available

Led By Paul Beaule, MD

Research Sponsored by MicroPort Orthopedics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening (first available), 2-5 years, 5-7 years, and 10 years

Awards & highlights

No Placebo-Only Group

Summary

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Eligible Conditions

Arthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening (first available), 2-5 years, 5-7 years, and 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening (first available), 2-5 years, 5-7 years, and 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (first available), 2-5 years, 5-7 years, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Component Survivorship

Secondary study objectives

Patient functional outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Total Hip ArthroplastyExperimental Treatment1 Intervention

Single group previously implanted with the following combination of components: PROFEMUR® TL modular femoral stem, MicroPort Orthopedics acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

total hip arthroplasty implant

2017

N/A

~30

Do I qualify?Apply below to find out