臨床研究等提出・公開システム

Date of registration	Dec. 01, 2021
Last modified on	Dec. 01, 2021
Trial ID	jRCT1062210054

Scientific Title	Effect of combined hyperbaric oxygen therapy on anterior cruciate ligament reconstruction
Public Title	Effect of combined hyperbaric oxygen therapy on anterior cruciate ligament reconstruction

Contact for Scientific Queries	Name	Enokida Makoto
	Affiliation	Tottori University
	Address	Nishimachi 36-1, Yonago, Tottori
	Telephone	+81-859386587
	E-mail	enokida@tottori-u.ac.jp
Contact for Public Queries	Name	Enokida Makoto
	Affiliation	Tottori University
	Address	Nishimachi 36-1, Yonago, Tottori
	Telephone	+81-859386587
	E-mail	enokida@tottori-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 01, 2021
Target sample size		80
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Men and women aged 14 to 45 at the time of consent, 2) Patients with traumatic anterior cruciate ligament injury (whether fresh or old), 3) Patients with consent from the substitute
	Exclusion Criteria	1)Patients with inflammatory disease 2) Patients with intra-articular fracture and osteochondral injury 3) Patients using bone metabolism regulators 4) Patients receiving hyperbaric oxygen therapy within 1 month prior to obtaining consent 5) Patients with compound ligament injury who require surgical treatment for ligament injuries other than the anterior cruciate ligament 6) Patients with a history of surgical treatment on the affected knee 7) Patients with physical or mental illness who cannot perform MRI examination 8) Chronic lung disease, chronic sinusitis, nasal polyps, upper respiratory tract inflammation and other sinus stenosis have been pointed out, pneumothorax history, other laryngological diseases, etc. 9) When it is judged that HBO continuation is not preferable due to the exacerbation of the underlying disease 10) Patients found to be pregnant
	Age Minimum	14age old over
	Age Maximum	45age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		anterior cruciate ligament injury
Intervention(s)		Hyperbaric oxygen (HBO) therapy. For the HBO combination group, HBO will be started the day after ACL reconstruction. A total of 10 times in a row excluding Saturdays and Sundays. The HBO protocol should be 2.0-2.5 ATA for 60-120 minutes, and a protocol that can reduce oxygen toxicity and other complications as much as possible and ensure efficacy will be adopted. We will use the HBO protocol implemented at our hospital, that is, "15 minutes pressurization, 60 minutes 2.0 ATA oxygen, 15 minutes decompression" with extremely few adverse events. The scientific basis is based on "Physiology and Medicine of Hyperbaric Oxygen Therapy". HBO discontinuation shall meet the discontinuation criteria.
Health Condition(s) Keyword		anterior cruciate ligament
Intervention(s) Keyword		hyperbaric oxygen therapy
Primary Outcome(s)		Evaluation of maturation of the anterior cruciate ligament by MRI
Secondary Outcome(s)		Quantitative evaluation of peripheral blood bone marrow-derived cell., Physical findings (knee joint swelling, muscle atrophy, range of motion, anterior movement amount, half-month movement amount over time), knee function evaluation, patient-standing knee function evaluation., Safety (adverse events, side effects)

Primary Sponsor	Tottori University Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Tottori University Ethical Review Boad
Address	Nishimachi 36-1, Yonago, Tottori
Telephone	+81-859386587
E-Mail	enokida@tottori-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 28, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none