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NCT04630262 · ClinicalTrials.gov registry record · NA
ATTUNE Cementless FB Tibial Base Clinical Study
A NA study, sponsored by DePuy Orthopaedics.
- Terminated
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT04630262: Clinical Trial NA study, sponsored by DePuy Orthopaedics.
NCT04630262 is a NA study that was terminated before completion, run by DePuy Orthopaedics. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04630262, a NA study, was terminated before completion, sponsored by DePuy Orthopaedics.
- TERMINATED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
This is a prospective, multi-center, non-randomized, single arm observational study. The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB and PS FB combined) implanted with the ATTUNE Cementless FB tray (primary and revision procedures) and will be analyzed when these patients have passed the 1 year preferred post-op window.
Primary Outcome
Functional Responder Rate with an Objective Performance Criteria of 85% as measured by the KOOS questionnaire for the first 225 tibia
Interventions
- DEVICE ATTUNE Cementless CR Fixed Bearing
- DEVICE ATTUNE Cementless PS Fixed Bearing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-05-09 |
| Est. Completion | 2023-03-31 |
| Phase | NA |
Why NCT04630262 stopped before completion
NCT04630262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which ATTUNE Cementless CR Fixed Bearing is the first listed.
NCT04630262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04630262 about?
NCT04630262 is a clinical study titled "ATTUNE Cementless FB Tibial Base Clinical Study". This is a prospective, multi-center, non-randomized, single arm observational study. The primary objective of this clinical investigation is to evaluate functional responder rates with an objective performance criteria (OPC) of 85% as measured by the KOOS questionnaire for the first 225 tibia (CR FB...
What is the current status of trial NCT04630262?
This trial is currently terminated. It is a NA study. The enrollment target is 80 participants. The study started on 2022-05-09. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT04630262?
The interventions under investigation include: ATTUNE Cementless CR Fixed Bearing (DEVICE), ATTUNE Cementless PS Fixed Bearing (DEVICE).
Who is sponsoring clinical trial NCT04630262?
This trial is sponsored by DePuy Orthopaedics, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04630262's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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