Effect of combined hyperbaric oxygen therapy on anterior cruciate ligament reconstruction

JRCT ID: jRCT1062210054

Registered date:01/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: anterior cruciate ligament injury
• Date of first enrollment: 01/12/2021
• Target sample size: 80
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Evaluation of maturation of the anterior cruciate ligament by MRI
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 14age old
• Age maximum: <= 45age old
• Gender: Both
• Include 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

Exclude 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

Related Information

• Primary Sponsor: Enokida Makoto