The Corticosteroid Meniscectomy Trial of Extended-Release Triamcinolone Injection After Arthroscopic Partial Meniscectomy: Protocol for a Double-Blind Randomized Controlled Trial

James K Sullivan; Julia R Gottreich; Peter B Imrey; Carl S Winalski; Xiaojuan Li; Kurt P Spindler; Patrick M Tomko; Charles L Cox; Rick W Wright; Morgan H Jones

doi:10.1177/23259671231150812

The Corticosteroid Meniscectomy Trial of Extended-Release Triamcinolone Injection After Arthroscopic Partial Meniscectomy: Protocol for a Double-Blind Randomized Controlled Trial

Orthop J Sports Med. 2023 Apr 21;11(4):23259671231150812. doi: 10.1177/23259671231150812. eCollection 2023 Apr.

Authors

James K Sullivan¹, Julia R Gottreich², Peter B Imrey^{1

3}, Carl S Winalski⁴, Xiaojuan Li^{4

5}, Kurt P Spindler⁶, Patrick M Tomko⁶, Charles L Cox⁷, Rick W Wright⁷, Morgan H Jones^{2

8}

Affiliations

¹ Cleveland Clinic Lerner College of Medicine of Case Western Reserve School of Medicine, Cleveland, Ohio, USA.
² Orthopaedic and Arthritis Center for Outcomes Research, Brigham and Women's Hospital, Boston, Massachusetts, USA.
³ Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, USA.
⁴ Imaging Institute, Cleveland Clinic, Cleveland, Ohio, USA.
⁵ Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
⁶ Department of Orthopaedic Surgery, Sports Medicine, Cleveland Clinic, Cleveland, Ohio, USA.
⁷ Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
⁸ Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA.

Abstract

Background: Meniscal tear in older adults often accompanies knee osteoarthritis and is commonly treated with arthroscopic partial meniscectomy (APM) when patients have persistent pain after a trial of physical therapy. Cross-sectional evidence suggests that synovitis is associated with baseline pain in this patient population, but little is known about the relationship between synovitis and postoperative recovery or progression of knee osteoarthritis.

Purpose/hypothesis: Intra-articular extended-release triamcinolone may reduce inflammation and thereby improve outcomes and slow disease progression. This article presents the rationale behind the Corticosteroid Meniscectomy Trial (CoMeT) and describes its study design and implementation strategies.

Study design: Randomized controlled trial.

Methods: CoMeT is a 2-arm, 3-center, randomized placebo-controlled trial designed to establish the clinical efficacy of extended-release triamcinolone administered via intra-articular injection immediately after APM. The primary outcome is change in Knee injury and Osteoarthritis Outcome Score Pain subscore at 3-month follow-up. Synovial biopsy, joint fluid aspirate, and urine and blood sample analyses will examine the associations between various objective measures of baseline inflammation and pre- and postoperative outcome measures and clinical responses to triamcinolone intervention. Quantitative 3-T magnetic resonance imaging will evaluate cartilage and meniscal composition and 3-dimensional bone shape to detect early joint degeneration.

Results: We discuss methodologic innovations and challenges.

Conclusion: To our knowledge, this is the first randomized double-blind clinical trial that will analyze the effect of extended-release triamcinolone acetonide on pain, magnetic resonance imaging measures of structural change and effusion/synovitis, soluble biomarkers, and synovial tissue transcriptomics after APM.

Keywords: Zilretta; arthroscopic partial meniscectomy; intra-articular injection; osteoarthritis; synovitis; triamcinolone.