The Effect of Hyperbaric Oxygen Therapy for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction(ACLR)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hyperbaric oxygen therapy.
- Who it may be relevant to
- Registry conditions: Anterior Cruciate Ligament Reconstruction. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Hyperbaric Oxygen Therapy (HBOT) for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction (ACLR): a Prospective, Randomized Control Study.
Overview
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.
Interventions
- Device hyperbaric 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.
Primary outcome measures
- International Knee Documentation Committee [Time frame: Change from Baseline immediately after the intervention]
Secondary outcome measures (12)
- Knee MRI [Time frame: Change from Baseline immediately after the intervention]
- Laxity ligament test [Time frame: Change from Baseline immediately after the intervention]
- physical measurement - ROM [Time frame: Change from Baseline immediately after the intervention]
- physical measurement - Edema [Time frame: Change from Baseline immediately after the intervention]
- physical measurement - Vas for pain [Time frame: Change from Baseline immediately after the intervention]
- physical measurement - Maximal quadriceps power by dynamometer [Time frame: Change from Baseline immediately after the intervention]
- Functional scores- (PROM) [Time frame: Change from Baseline immediately after the intervention]
- Functional scores - Vas for global rating of knee function [Time frame: Change from Baseline immediately after the intervention]
- Short form health survey (sf-36) [Time frame: Change from Baseline immediately after the intervention]
- Functional measurement [Time frame: Change from Baseline immediately after the intervention]
- Functional measurement - (SEBT) [Time frame: Change from Baseline immediately after the intervention]
- Functional measurement - Single Hop test [Time frame: Change from Baseline immediately after the intervention]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh — Zrifin
Identifiers
NCT: NCT06493851 · 0166-23