MDR - PMCF Study for Taperloc Complete Stems
RecruitingNCT04028687
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems
- Conditions
- Hip Arthritis
- Hip Disease
- Hip Fractures
- Hip Injuries
- Hip Pain Chronic
- Interventions
- Device: Taperloc Complete Stem
- Sponsor
- Zimmer Biomet
- Start date
- 2020-02-13
- Primary completion
- 2032-02-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04028687