Actively Recruiting
Post Market Clinical Follow-up Study to Confirm Safety, Performance, and Benefits of Taperloc Complete Stems in Hip Replacement
Led by Zimmer Biomet · Updated on 2025-03-11
820
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting data to confirm the safety, performance, and clinical benefits of the Taperloc Complete stems used in primary or revision total hip replacement surgeries. This observational study gathers both past and new information from patients who received these implants, aiming to follow their outcomes at 1, 3, 5, 7, and 10 years after surgery. The study focuses on understanding how well the implant works and its safety over time. The study involves patients who have been implanted with the Taperloc Complete Stem to treat hip conditions such as arthritis, fractures, injuries, or chronic pain. Data will be collected retrospectively from existing records and prospectively to reach the 10-year follow-up. The main goal is to track safety by recording any implant revisions, complications, or adverse events, while also assessing clinical benefits through patient-reported outcome measures. Participants will have their health monitored through clinical assessments including the Harris Hip Score and Oxford Hip Score up to 10 years after implantation. Researchers will collect information on any complications or revisions related to the implant. Patients will provide consent and their progress will be tracked over time to measure the device's safety and performance as part of routine follow-up care.
CONDITIONS
Brief 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
- Indications include non-inflammatory degenerative joint disease such as 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
You will not qualify if you...
- Off-label use of the implant
- Infection, sepsis, or osteomyelitis
- Uncooperative patient or patient 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, marked bone loss, or bone resorption visible on X-ray
- Vascular insufficiency, muscular atrophy, or neuromuscular disease
- Patient is known to be pregnant or nursing
- Patient is a prisoner
- Known alcohol or drug abuse
- Psychiatric illness or cognitive deficit preventing proper informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants who have been implanted with a Taperloc Complete Stem are monitored to confirm safety, performance, and clinical benefits through periodic assessments up to 10 years after surgery.
Visits at approximately 1, 3, 5, 7, and 10 years post-implantation
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
L
Lynsey Boyle
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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