Meniscal Transplant surgery or Optimised Rehabilitation full randomised trial (MeTeOR2): a study protocol

Area of Science:

• Orthopedics
• Regenerative Medicine
• Clinical Trials

Background:

• Persistent pain and disability after meniscectomy present a significant lifelong challenge, particularly for young individuals.
• Limited effective treatment options exist, prompting exploration of advanced surgical interventions like meniscal allograft transplantation (MAT).
• The comparative effectiveness and cost-effectiveness of MAT versus non-surgical rehabilitation remain largely unknown.

Purpose of the Study:

• To compare the clinical and cost-effectiveness of meniscal allograft transplantation (MAT) against personalized knee therapy (PKT).
• To evaluate MAT and PKT as treatment options for individuals with pain and disability following meniscectomy.
• To provide evidence for optimal management strategies for post-meniscectomy knee conditions.

Main Methods:

• An international, multicentre, randomized controlled trial comparing MAT with personalized knee therapy (PKT).
• Recruitment of 144 participants across the UK, Australia, Canada, and Belgium.
• Primary outcome measured by the Knee injury and Osteoarthritis Outcome Score (KOOS4) at 24 months, with secondary outcomes and economic evaluation over the same period.

Main Results:

• Data collection for clinical outcomes, cost-effectiveness, and secondary endpoints is ongoing.
• The study is powered to detect a clinically significant difference in KOOS4 scores between treatment groups.
• Intention-to-treat analysis will be employed, adhering to CONSORT guidelines.

Conclusions:

• The Meniscal Transplant surgery or Optimised Rehabilitation (MTOpT) trial will provide crucial data on the comparative effectiveness of MAT and PKT.
• Findings will inform clinical decision-making and healthcare policy regarding the management of post-meniscectomy pain and disability.
• The study addresses a critical knowledge gap in optimizing knee function and patient quality of life after meniscal surgery.