MDR - PMCF Study for Taperloc Complete Stems

Part of paid clinical trials in Henderson, Nevada.

Sponsor
Zimmer Biomet
Study ID
NCT04028687
Status
Recruiting
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Conditions

  • Hip Arthritis
  • Hip Disease
  • Hip Fractures
  • Hip Injuries
  • Hip Pain Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 13, 2020
Status verified
Mar 2025
Primary completion
Feb 12, 2032
Completion
Feb 12, 2032

Study Design

Enrollment
820 participants (estimated)

Arms

  • Arm: Taperloc Complete Stems
    Patients that have been implanted with a Taperloc Complete Stem to repair hip malfunction/disease.

Primary Outcome Measure

Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events. [ Time Frame: Out to 10 Years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Orthopaedic Institute of HendersonHendersonNevada89052-
Texas Health Physicians GroupPlanoTexas75243
Shuvie Dasgupta
[email protected]
972-981-7114
Roger Emerson, MD (PRINCIPAL_INVESTIGATOR)
Kwame Ennin, MD (SUB_INVESTIGATOR)
Proliance Orthopaedics and Sports MedicineBellevueWashington98004-

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By research site
Orthopaedic Institute of Henderson· Henderson, NVTexas Health Physicians Group· Plano, TXProliance Orthopaedics and Sports Medicine· Bellevue, WA

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