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Recruiting Not applicable NCT06493851

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

No applicable phase (e.g. observational)
Conditions: Anterior Cruciate Ligament Reconstruction

Sponsor: Assaf-Harofeh Medical Center

trial.available_in: БГ
Overview
The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.
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.
Who can participate
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
Interventions
hyperbaric oxygen therapy
DEVICE
Locations 1
Israel (1)
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Zrifin
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
45 Years
Healthy volunteers
No
Start date
15.09.2024
Completion date
01.01.2028
Registry ID
NCT06493851
Source
clinicaltrials.gov
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