NCT05505747

Enhancing Recovery Through a Combined Mechanobiologic Intervention Following Meniscus Repair

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Austin V Stone · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Arthroscopic meniscal procedures are the most commonly performed orthopaedic procedure in the U.S. affecting 15% of Americans ages 10-65 years. Meniscus injury is also known to increase the risk of posttraumatic osteoarthritis (PTOA). The current randomized clinical trial will test a novel intervention after meniscal repair that combines an oral senolytic fisetin and real-time biofeedback program to restore joint loading and subsequent return to activity.

Detailed description

Arthroscopic meniscal procedures are the most commonly performed orthopaedic procedure in the U.S. affecting 15% of Americans ages 10-65 years. Meniscus injury is also known to increase the risk of posttraumatic osteoarthritis (PTOA). The current randomized clinical trial will test a novel mechanobiologic intervention after meniscal repair that combines an oral senolytic fisetin and real-time biofeedback program to restore joint loading and subsequent return to activity. The premise for this program is derived from growing evidence that under-loading early after an orthopedic surgery is a major contributing factor to future PTOA development. Despite the need to assess how much force the patient can produce in various exercises to better inform progression and progress, clinicians still have few tools. By providing the realtime feedback during all exercises, the program will promote the recovery of muscle function as well which is critical for normal joint loading. The study will 1) evaluate the feasibility and acceptability of the mechanobiologic intervention following arthroscopic repair of meniscus tears, 2) determine if the mechanobiologic intervention improves physical function, patient reported outcomes, loading and muscle strength, and biomechanical symmetry in comparison to standard of care physical therapy and oral placebo, and 3) compare cartilage composition at 1 year after meniscus surgery between the mechnobiologic intervention and a control group treated standard of care physical therapy and oral placebo.

Conditions

• Meniscus Tear
• Meniscus; Derangement
• Meniscus Lesion
• Meniscus Disorder

Interventions

Type	Name	Description
DRUG	Fisetin	Fisetin is a plant flavanol senolytic found in strawberries, persimmons, and cucumbers. This naturally derived senolytic has few side effects and previous animal models of both osteoarthritis and rheumatoid arthritis have demonstrated that the senolytic supplement fisetin reduces inflammation and slows cartilage breakdown.
DRUG	Placebo oral capsule	The oral placebo will consist of corn starch and gelatin capsules

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2022-08-18
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study