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Success of Long-acting Anti-inflammatories After Anterior Cruciate Ligament and Meniscal Injury

NCT04331002 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-07-27

Study results available
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Summary

The purpose of this study is to determine if extended-release triamcinolone acetonide treatment alters the progressive changes in bone shape previously demonstrated after anterior cruciate ligament (ACL) reconstruction with partial meniscectomy or meniscal repair.

Conditions

  • Tibial Meniscus Injuries
  • Tibial Meniscus Tears
  • Tibial Meniscus, Torn
  • Anterior Cruciate Ligament Tear

Interventions

DRUG

Zilretta

ZILRETTA is an injectable suspension that delivers 32 mg of triamcinolone acetonide. It is supplied as a single-dose kit containing one vial of ZILRETTA microsphere powder, one vial of 5 mL diluent, and one sterile vial adapter.

OTHER

Placebo

5 mL normal saline

Sponsors & Collaborators

  • Austin V Stone

    lead OTHER

Principal Investigators

  • Austin Stone, MD, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-21
Primary Completion
2022-07-11
Completion
2022-07-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331002 on ClinicalTrials.gov