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NCT04027140 · ClinicalTrials.gov registry record
MDR - M/L Taper With Kinectiv Technology Stems and Necks
A clinical trial, sponsored by Zimmer Biomet.
- Terminated
- Registry status
- 36
- Enrollment target
NCT04027140: Clinical Trial study, sponsored by Zimmer Biomet.
NCT04027140 is a clinical trial that was terminated before completion, run by Zimmer Biomet. The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04027140 was terminated before completion, sponsored by Zimmer Biomet.
- TERMINATED
- Registry status
- 36 participants
- Enrollment target
Study Summary
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip arthroplasty (implants) at 1,2,5 and 10-year follow-up\*. ML Taper with Kinectiv Technology has been on the market since 2008, but has insufficient long term clinical data. Therefore, 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 the 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.
Interventions
- DEVICE M/L Taper with Kinectiv Technology Stems and Necks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-01-22 |
| Est. Completion | 2024-11-05 |
Why NCT04027140 stopped before completion
NCT04027140 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which M/L Taper with Kinectiv Technology Stems and Necks is the first listed.
NCT04027140 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04027140 about?
NCT04027140 is a clinical study titled "MDR - M/L Taper With Kinectiv Technology Stems and Necks". The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip arthroplasty (implants) at 1,2,5 and 10-year follow-up\*. ML Taper with Ki...
What is the current status of trial NCT04027140?
This trial is currently terminated. The enrollment target is 36 participants. The study started on 2020-01-22. Estimated completion is 2024-11-05.
What interventions are being tested in trial NCT04027140?
The interventions under investigation include: M/L Taper with Kinectiv Technology Stems and Necks (DEVICE).
Who is sponsoring clinical trial NCT04027140?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
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