About this trial
The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Inability to attend scheduled clinic visits and/or comply with the study protocol
Additional injury
An inability to perform MRI.
Active malignancy
Trial design
Parallel
Treatments tested in this trial
hyperbaric oxygen therapy
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
International Knee Documentation Committee
The aim of the international knee documentation committee (IKDC) is to detect improvement or deterioration in symptoms, function, and sport activity following knee impairment. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Secondary outcomes
Knee MRI
At each of the evaluations, patients will undergo structural MRI scanning. Images will be acquired on MAGNETOM Vida 3T Scanner, configured with a channel receiver knee coils (Siemens Healthcare, Erlangen, Germany) at Shamir medical centre. Edema and haemorrhage are seen as increased signal in the substance of the ACL in an acute injury.
Laxity ligament test
Laxity ligament test includes 2 parts: 1- Lachman, anterior drawer, pivot - Manual assessment of the knee joint stabilization, The result will recorded as normal to severely abnormal according to criteria established by the IKDC. 2- KT-1000 - The KT-1000 test is knee arthrometer assessment for ACL laxity, The results of the KT-1000 examination will be recorded as normal to severely abnormal according to guidelines established by the IKDC .
physical measurement - ROM
ROM - Range of motion will be assessed with the patient in the supine position using a goniometer, passive knee flexion will be rated normal to severely abnormal according to established IKDC guidelines.
physical measurement - Edema
Edema- One of the common measurement methods in research is knee perimetry, the assessor measures the knee girth at 3 points: the fold at the popliteal fossa (P0), 5 cm above P0 (PA), and 5 cm below P0 (PB). Data on perimetry were calculate.
Locations
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Sponsors and contacts
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