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 long-term follow-up study is collecting safety and outcomes data from patients who have received the Taperloc Complete hip stem — a device used in total hip replacement surgery — to confirm its safety, performance, and clinical benefits at 1, 3, 5, 7, and 10 years after implantation. Hip replacement is commonly performed for osteoarthritis, rheumatoid arthritis, fractures, and other conditions, and post-market follow-up is required to ensure ongoing device safety. Adults aged 18 or older who are skeletally mature and have undergone primary or revision hip arthroplasty with the Taperloc Complete stem for an approved indication are eligible, while those with active infection, osteoporosis, psychiatric illness, or pregnancy are excluded. Participation involves chart reviews and completion of validated patient-reported outcome questionnaires at scheduled follow-up time points. This summary was prepared to help patients understand the study in plain language.

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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