MDR - PMCF Study for Taperloc Complete Stems
Recruiting now
Conditions studied: Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries, Hip Pain Chronic
In brief
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 facts
- Study ID
- NCT04028687
- Run by
- Zimmer Biomet
- People needed
- 820
- Starts
- 2020-02-13
- Expected to finish
- 2032-02-12
- Last updated by the study team
- 2025-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Texas Health Physicians Group — Plano, Texas, United States (enrolling)
- Orthopaedic Institute of Henderson — Henderson, Nevada, United States
- Proliance Orthopaedics and Sports Medicine — Bellevue, Washington, United States
Full record on ClinicalTrials.gov
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