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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorAssaf-Harofeh Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • hyperbaric oxygen therapy

    Device

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: hyperbaric oxygen therapy (HBOT) active treatmentActive comparator 1 intervention
Group B: hyperbaric oxygen therapy (HBOT) Sham treatmentSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Change from Baseline immediately after the intervention

Secondary outcomes

1

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.

Time frame
Change from Baseline immediately after the intervention
2

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 .

Time frame
Change from Baseline immediately after the intervention
3

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.

Time frame
Change from Baseline immediately after the intervention
4

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.

Time frame
Change from Baseline immediately after the intervention

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)Recruiting70300, ZrifinIsraelIsrael

Sponsors and contacts

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