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NCT03653416 · ClinicalTrials.gov registry record · Phase 4

Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty

A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 4
Development phase
99
Enrollment target

NCT03653416: Completed Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT03653416 is a Phase 4 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 99 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03653416, a Phase 4 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 4
Development phase
99 participants
Enrollment target

Study Summary

Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.

Primary Outcome

Narcotic consumption in the first 24 hours

Interventions

  • DRUG Bupivacaine
  • DEVICE Ipack
  • PROCEDURE Peri Articular Infiltration

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2018-03-01
Est. Completion 2019-08-01
Phase Phase 4

What the finished NCT03653416 record still lists

NCT03653416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).

The record links to 0 conditions, and to 3 interventions - of which Bupivacaine is the first listed.

NCT03653416 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03653416 about?

NCT03653416 is a clinical study titled "Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty". Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.

What is the current status of trial NCT03653416?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 99 participants. The study started on 2018-03-01. Estimated completion is 2019-08-01.

What interventions are being tested in trial NCT03653416?

The interventions under investigation include: Bupivacaine (DRUG), Ipack (DEVICE), Peri Articular Infiltration (PROCEDURE).

Who is sponsoring clinical trial NCT03653416?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03653416's enrollment target sits among peer trials

99 853rd of 2000 higher than 1,147 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT03653416, the US trial registry maintained by the National Library of Medicine. NCT03653416 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.