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NCT05337696 · ClinicalTrials.gov registry record · NA
Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT05337696: Clinical Trial NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05337696 is a NA study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05337696, a NA study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK (VIP) implant in the treatment of symptomatic, acute (\<8week) vertebral compression fractures who have failed conservative care strategies.
Primary Outcome
Safety will be measured by number of device related serious adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Interventions
- PROCEDURE Vertebral Implant PEEK Procedure
- DEVICE Vertebral Implant PEEK (VIP) implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2022-05-10 |
| Est. Completion | 2025-03-07 |
| Phase | NA |
Why NCT05337696 stopped before completion
NCT05337696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Vertebral Implant PEEK Procedure is the first listed.
NCT05337696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05337696 about?
NCT05337696 is a clinical study titled "Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant". The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK (VIP) implant in the treatment of symptomatic, acute (\<8week) vertebral compression fractures who have failed c...
What is the current status of trial NCT05337696?
This trial is currently terminated. It is a NA study. The enrollment target is 23 participants. The study started on 2022-05-10. Estimated completion is 2025-03-07.
What interventions are being tested in trial NCT05337696?
The interventions under investigation include: Vertebral Implant PEEK Procedure (PROCEDURE), Vertebral Implant PEEK (VIP) implant (DEVICE).
Who is sponsoring clinical trial NCT05337696?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05337696's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 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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