Status:
RECRUITING
MDR - PMCF Study for Taperloc Complete Stems
Lead Sponsor:
Zimmer Biomet
Conditions:
Hip Arthritis
Hip Disease
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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 according to a cleared indication, which includes the following:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Exclusion
- Off-label use
- Infection
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Osteoporosis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy, or neuromuscular disease
- Patient is known to be pregnant or nursing
- Patient is a prisoner
- Patient is a known alcohol or drug abuser
- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
Key Trial Info
Start Date :
February 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 12 2032
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT04028687
Start Date
February 13 2020
End Date
February 12 2032
Last Update
March 11 2025
Active Locations (3)
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1
Orthopaedic Institute of Henderson
Henderson, Nevada, United States, 89052
2
Texas Health Physicians Group
Plano, Texas, United States, 75243
3
Proliance Orthopaedics and Sports Medicine
Bellevue, Washington, United States, 98004