MDR - PMCF Study for Taperloc Complete Stems
Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems
1 other identifier
observational
820
1 country
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedStudy Start
First participant enrolled
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 12, 2032
March 11, 2025
March 1, 2025
12 years
July 18, 2019
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events.
The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to either implant or instrumentation should be specified.
Out to 10 Years
Secondary Outcomes (2)
Device Performance and Benefits evaluated through the Harris Hip Score
Out to 10 Years
Device Performance and Benefits evaluated through the Oxford Hip Score
Out to 10 Years
Study Arms (1)
Taperloc Complete Stems
Patients that have been implanted with a Taperloc Complete Stem to repair hip malfunction/disease.
Interventions
Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.
Eligibility Criteria
A consecutive series of patients implanted with the Taperloc Complete Stems in primary or revision total hip arthroplasty according to the approved indications.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (3)
Orthopaedic Institute of Henderson
Henderson, Nevada, 89052, United States
Texas Health Physicians Group
Plano, Texas, 75243, United States
Proliance Orthopaedics and Sports Medicine
Bellevue, Washington, 98004, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2019
First Posted
July 23, 2019
Study Start
February 13, 2020
Primary Completion (Estimated)
February 12, 2032
Study Completion (Estimated)
February 12, 2032
Last Updated
March 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share