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NCT04028687 · ClinicalTrials.gov registry record
MDR - PMCF Study for Taperloc Complete Stems
A clinical trial of Hip Fractures and Hip Injuries, sponsored by Zimmer Biomet.
- Recruiting
- Registry status
- 820
- Enrollment target
- 3
- Study locations
NCT04028687: Recruiting study of Hip Fractures and Hip Injuries, sponsored by Zimmer Biomet.
NCT04028687 is a study of Hip Fractures and Hip Injuries that is actively recruiting participants, run by Zimmer Biomet. The registered enrollment target is 820 participants, above the 567-participant average among 15 other Hip Fractures trials with a reported enrollment target (45% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04028687, a study of Hip Fractures and Hip Injuries, is actively recruiting participants, sponsored by Zimmer Biomet.
- RECRUITING
- Registry status
- 820 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Taperloc Complete Stem
Study Locations (3)
Nevada
- Orthopaedic Institute of Henderson - Henderson
Texas
- Texas Health Physicians Group - Plano
Washington
- Proliance Orthopaedics and Sports Medicine - Bellevue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 820 participants |
| Start Date | 2020-02-13 |
| Est. Completion | 2032-02-12 |
What NCT04028687 shows while recruiting
NCT04028687 is an observational study that tracks outcomes without assigning an intervention. The registered 820 participants enrollment target is mid-sized for trials with a published cap, above the 567-participant average among 15 other Hip Fractures trials with a reported enrollment target (45% higher).
The record links to 5 conditions, with Hip Fractures appearing as the primary indexed condition, and to 1 intervention - of which Taperloc Complete Stem is the first listed.
NCT04028687 reports a single indexed study location in Nevada, Texas, Washington.
Frequently Asked Questions
What is clinical trial NCT04028687 about?
NCT04028687 is a clinical study titled "MDR - PMCF Study for Taperloc Complete Stems". 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 t...
What is the current status of trial NCT04028687?
This trial is currently recruiting. The enrollment target is 820 participants. The study started on 2020-02-13. Estimated completion is 2032-02-12.
What conditions does trial NCT04028687 study?
This clinical trial studies the following conditions: Hip Fractures, Hip Injuries, Hip Arthritis, Hip Pain Chronic, Hip Disease.
What interventions are being tested in trial NCT04028687?
The interventions under investigation include: Taperloc Complete Stem (DEVICE).
Who is sponsoring clinical trial NCT04028687?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04028687 being conducted?
This trial has 3 study locations across Nevada, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04028687's enrollment target sits among peer trials
820 5th of 15 higher than 11 of 15 other Hip Fractures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hip Fractures trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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