Study protocol for a randomised placebo controlled trial of platelet-rich plasma injection to prevent post-traumatic knee osteoarthritis after anterior cruciate ligament reconstruction
Masashi Nagao,
Yoshitomo Saita,
Muneaki Ishijima,
Yohei Kobayashi,
Keiji Kobayashi,
Haruka Kaneko,
Hirofumi Nishio,
Yasumasa Momoi,
Ryosuke Nakajima,
Sayuri Uchino,
Takanori Wakayama,
Shin Fukusato,
Suguru Wakana,
Jun Tomura,
Keiichi Yoshida,
Mitsuaki Kubota
Affiliations
Masashi Nagao
5 Medical Technology Innovation Center, Juntendo University, Bunkyo-ku, Tokyo, Japan
Yoshitomo Saita
Department of Sports and Regenerative Medicine, Juntendo University Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan
Muneaki Ishijima
1 Sportology Center, Juntendo University Graduate School of Medicine, Tokyo, Japan
Yohei Kobayashi
Department of Sports and Regenerative Medicine, Juntendo University Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan
Keiji Kobayashi
1Department of Orthopaedics and Sports Medicine, Juntendo University, Tokyo, Japan
Haruka Kaneko
Departments of Anesthesiology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan
Hirofumi Nishio
Department of Sports and Regenerative Medicine, Juntendo University Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan
Yasumasa Momoi
Departments of Orhopedics, Faculty of Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan
Ryosuke Nakajima
Departments of Orhopedics, Faculty of Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan
Sayuri Uchino
Departments of Orhopedics, Faculty of Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan
Takanori Wakayama
Departments of Orhopedics, Faculty of Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan
Shin Fukusato
Departments of Orhopedics, Faculty of Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan
Suguru Wakana
Departments of Orhopedics, Faculty of Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan
Jun Tomura
Departments of Orhopedics, Faculty of Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan
Keiichi Yoshida
Departments of Orhopedics, Faculty of Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan
Mitsuaki Kubota
Departments of Orhopedics, Faculty of Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan
Introduction The elevated cytokine levels in patients suffering from anterior cruciate ligament (ACL) rupture may lead to acute post-traumatic arthritis (APTA) and post-traumatic osteoarthritis (PTOA). Due to its chondrogenerative and anti-inflammatory effect, platelet-rich plasma (PRP) therapy is expected to show a positive outcome in APTA and PTOA. The proposed trial aims to quantitatively measure the efficacy of PRP injection in arresting post-traumatic cartilage degeneration among patients after ACL reconstruction.Methods and analysis This will be a single-blind, randomised, prospective, controlled clinical trial designed following the Consolidated Standards of Reporting Trials guidelines. After ACL reconstruction, 80 patients will be randomised to receive either leucocyte-poor PRP injection after joint aspiration or a placebo control group receiving only joint aspiration. Participants (age 20–49 years) will be those who have undergone ACL reconstruction within the past 2 weeks with a body mass index<35 and Kellgren Lawrence osteoarthritis grade<2. The primary outcome will include MRI-T2 values of knee cartilage at 6 months. The secondary outcomes will include pain assessment by Visual Analogue Scale, Knee injury and Osteoarthritis Outcome Score, blood and urine test, physical findings, measurements for muscle strength and joint stability.Ethics and dissemination The study was approved by The Independent Ethics Committee for Clinical Trials of the Japanese Association for the Promotion of State-of-the-Art Medicine. Results of the trial and each of the outcomes will be shared via conferences and publication in a peer-reviewed journal.Trial registration number jRCTb030200391.
