RecruitingNot ApplicableNCT06493851

The Effect of Hyperbaric Oxygen Therapy for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction(ACLR)

The Effect of Hyperbaric Oxygen Therapy (HBOT) for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction (ACLR): a Prospective, Randomized Control Study.


Sponsor

Assaf-Harofeh Medical Center

Enrollment

40 participants

Start Date

Sep 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • Subjects willing and able to read, understand and sign an informed consent
  • Age 18-45
  • Anterior cruciate ligament tear for reconstruction (with or without meniscal repair).

Exclusion Criteria10

  • Inability to attend scheduled clinic visits and/or comply with the study protocol
  • Additional injury
  • An inability to perform MRI.
  • Active malignancy
  • Chest pathology incompatible with pressure changes (including active asthma)
  • Ear or sinus pathology incompatible with pressure changes
  • History of epilepsy
  • Claustrophobia
  • Previous knee surgery
  • Participation in another study

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Interventions

DEVICEhyperbaric oxygen therapy

The HBOT protocol consists of 6 weeks protocol including 5 daily HBOT sessions per week (total of 30), each session lasts 90 minutes, of 100% oxygen at 2 atmosphere absolute (ATA) with 5-minute air breaks every 20 minutes. Investigational product: Multiplace hyperbaric oxygen chamber (Haux Starmed 2700, Germany) located at the Sagol center for hyperbaric medicine and research, Shamir (Assaf-Harofeh) Medical Center, Israel.


Locations(1)

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)

Zrifin, Israel

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NCT06493851


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