Clinical trial NCT06493851: The Effect of Hyperbaric Oxygen Therapy for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction(ACLR)
Official title: The Effect of Hyperbaric Oxygen Therapy (HBOT) for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction (ACLR): a Prospective, Randomized Control Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: hyperbaric oxygen therapy
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: hyperbaric oxygen therapy (2ATA, 100% oxygen) vs. sham (1.2ATA, 21% oxygen)
Primary purpose: TREATMENT

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

Detailed description: ACL rapture (Anterior cruciate ligament reconstruction rehabilitation) is a common injury in sports and cause severe functional problem. The big concern with this injury is the time to return to sport, this is the interest of the athlete.

The preferred treatment today when it comes to active athletes is to have an anterior cruciate ligament reconstruction (ACLR) ,the return to high function and sports after anterior cruciate ligament reconstruction (ACLR) surgery lasts about 8 months.

In the last few years, knowledge has been accumulating regarding the effectiveness of the new hyperbaric oxygen protocols in accelerating the healing of wounds and tissue damage. it was found that Hyperbaric oxygen therapy (HBOT) for ligament injuries in mice improves the quality and speed of recovery. The effect of HBOT on the rate of ligament healing has not yet been properly tested in humans.

The constant search for accelerated recovery in sports injuries along with the benefit of the HBOT in tissue healing processes encouraged the need to investigate the rate of recovery after a sports injury under HBOT. Two previous human studies in which medial collateral tear was tested showed positive effect on pain, physical outcome (decreased edema, range of motion and maximal knee flex) and accelerate the return to play. These findings with the fact that ACL injuries are common among athletes and can limit return to sports, reinforce the need to examine the effect of HBOT following ACLR in the terms of improving and speeding up recovery.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: International Knee Documentation Committee
timeFrame: Change from Baseline immediately after the intervention
Secondary outcomes:
measure: Knee MRI
timeFrame: Change from Baseline immediately after the intervention
measure: Laxity ligament test
timeFrame: Change from Baseline immediately after the intervention
measure: physical measurement - ROM
timeFrame: Change from Baseline immediately after the intervention
measure: physical measurement - Edema
timeFrame: Change from Baseline immediately after the intervention
measure: physical measurement - Vas for pain
timeFrame: Change from Baseline immediately after the intervention
measure: physical measurement - Maximal quadriceps power by dynamometer
timeFrame: Change from Baseline immediately after the intervention
measure: Functional scores- (PROM)
timeFrame: Change from Baseline immediately after the intervention
measure: Functional scores - Vas for global rating of knee function
timeFrame: Change from Baseline immediately after the intervention
measure: Short form health survey (sf-36)
timeFrame: Change from Baseline immediately after the intervention
measure: Functional measurement
timeFrame: Change from Baseline immediately after the intervention
measure: Functional measurement - (SEBT)
timeFrame: Change from Baseline immediately after the intervention
measure: Functional measurement - Single Hop test
timeFrame: Change from Baseline immediately after the intervention
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Study officials:
affiliation: Asaf-Harofhe MC
name: Shai a Efrati, MD
role: PRINCIPAL_INVESTIGATOR
References: