MDR - PMCF Study for Taperloc Complete Stems
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
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 criteria
Qualifiers
Patient must be 18 years of age or older and skeletally mature
Patient must be willing and able to sign IRB approved informed consent
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Disqualifiers
Off-label use
Infection
Sepsis
Osteomyelitis
Trial design
Treatments tested in this trial
- Taperloc Complete Stem
Treatment groups
820 Participants
are divided into 1 treatment groupLocations
3Orthopaedic Institute of Henderson89052, HendersonNevada, United States
Texas Health Physicians Group75243, PlanoTexas, United States
Proliance Orthopaedics and Sports Medicine98004, BellevueWashington, United States
Sponsors and collaborators
Zimmer Biomet
Lead sponsor
Source ClinicalTrials.gov