Actively Recruiting
MDR - PMCF Study for Taperloc Complete Stems
Led by Zimmer Biomet · Updated on 2025-03-11
820
Participants Needed
3
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MDR - PMCF Study for Taperloc Complete Stems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older and skeletally mature
- Patient must be willing and able to sign IRB approved informed consent
- Patient must have undergone primary or revision hip arthroplasty with the Taperloc Complete stem for approved indications including non-inflammatory degenerative joint disease, osteoarthritis, avascular necrosis, rheumatoid arthritis, correction of functional deformity, treatment of non-union, femoral neck fracture, and certain trochanteric fractures
You will not qualify if you...
- Off-label use of the implant
- Presence of infection, sepsis, or osteomyelitis
- Uncooperative patients or those with neurologic disorders unable to follow directions
- Osteoporosis or metabolic disorders impairing bone formation
- Osteomalacia
- Distant infections that may spread to the implant site
- Rapid joint destruction or marked bone loss visible on X-ray
- Vascular insufficiency, muscular atrophy, or neuromuscular disease
- Known pregnancy or nursing
- Prisoner status
- Known alcohol or drug abuse
- Psychiatric illness or cognitive deficits preventing proper informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Orthopaedic Institute of Henderson
Henderson, Nevada, United States, 89052
Withdrawn
2
Texas Health Physicians Group
Plano, Texas, United States, 75243
Actively Recruiting
3
Proliance Orthopaedics and Sports Medicine
Bellevue, Washington, United States, 98004
Withdrawn
Research Team
M
Megan McKinnie
CONTACT
L
Lynsey Boyle
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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