RecruitingNCT04028687

MDR - PMCF Study for Taperloc Complete Stems

Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems


Sponsor

Zimmer Biomet

Enrollment

820 participants

Start Date

Feb 13, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is a long-term follow-up registry for patients who have received the Taperloc Complete hip stem implant during hip replacement surgery. The goal is to collect real-world data on how well this implant performs over time — including how often complications arise and how patients' quality of life and function improve after surgery. This type of study, called a Post-Market Clinical Follow-up (PMCF), is required to ensure medical devices continue to meet safety and performance standards after they are approved. Participants will be followed over several years with periodic check-ins. You may be eligible if: - You are 18 years of age or older and skeletally mature - You have undergone primary or revision hip replacement surgery using the Taperloc Complete stem - Your surgery was for osteoarthritis, avascular necrosis, rheumatoid arthritis, functional deformity, or certain hip fractures - You are willing to sign informed consent You may NOT be eligible if: - You have an active infection, sepsis, or osteomyelitis - You have significant osteoporosis, bone loss, or metabolic bone disease - You have a neurological or psychiatric condition that prevents following study directions - You are pregnant, a prisoner, or a known substance abuser Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETaperloc Complete Stem

Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.


Locations(3)

Orthopaedic Institute of Henderson

Henderson, Nevada, United States

Texas Health Physicians Group

Plano, Texas, United States

Proliance Orthopaedics and Sports Medicine

Bellevue, Washington, United States

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NCT04028687


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