Anterior Cruciate Ligament ReconstructionNCT06493851
The Effect of Hyperbaric Oxygen Therapy for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction(ACLR)
A study testing hyperbaric oxygen therapy in people with Anterior Cruciate Ligament Reconstruction, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- hyperbaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Sep 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
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- History of epilepsy
- Claustrophobia
- Previous knee surgery
- Participation in another study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)
Zrifin, 70300
Shai Efrati, Prof, 972-8-9779393, efratishai@outlook.com
About this study
Official title: The Effect of Hyperbaric Oxygen Therapy (HBOT) for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction (ACLR): a Prospective, Randomized Control Study.
The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.
Read the 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.
- Being tested
- hyperbaric oxygen therapy
- Keywords
- hyperbaric oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric oxygen therapy (HBOT) active treatment | Active comparator | 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. Receives: Device: hyperbaric oxygen therapy |
| hyperbaric oxygen therapy (HBOT) Sham treatment | Sham comparator | The sham HBOT protocol consists of 6 weeks protocol including 5 daily sham HBOT sessions per week (total of 30), each session includes breathing 21% oxygen by mask in a sham multiplace chamber. Sham pressure will go up to 1.2 ATA during the first five minutes of the session (to stimulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 90 minutes with 5-minute air breaks every 20 minutes. Receives: Device: hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline immediately after the intervention
Secondary outcomes (12)
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.
Measured: Change from Baseline immediately after the intervention
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 .
Measured: Change from Baseline immediately after the intervention
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.
Measured: Change from Baseline immediately after the intervention
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.
Measured: Change from Baseline immediately after the intervention
physical measurement - Vas for pain
Vas for pain - Pain scales are useful for the assessment of postoperative pain and based on self-reporting and represent subjective pain intensity, The evaluation is performed according to the IKDC : 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).
Measured: Change from Baseline immediately after the intervention
physical measurement - Maximal quadriceps power by dynamometer
Maximal quadriceps power by dynamometer - Quadriceps strength after ACLR usually assessed by isometric dynamometry and comparison the strength of the ACLR limb with the uninjured limb.
Measured: Change from Baseline immediately after the intervention
Functional scores- (PROM)
Tegner Lysholm knee scoring scale - patient-reported outcome measure (PROM) ,The total score is the sum of each response to the eight questions and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disabilities, Score are categorized as excellent (95-100), good (84-94), fair (65-83), and poor (<64).
Measured: Change from Baseline immediately after the intervention
Functional scores - Vas for global rating of knee function
Vas for global rating of knee function - measure the participation restrictions experienced during activities of daily living and sports by patients with a history of ACLR. rating of function by assessing the level of knee function on a 0 to 100 scale, with 0 points representing complete loss of function due to their knee injury and 100 points representing their level of function prior to their knee injury.
Measured: Change from Baseline immediately after the intervention
Short form health survey (sf-36)
Quality of life questionnaire, scale of 0-100, higher score means better outcome
Measured: Change from Baseline immediately after the intervention
Functional measurement
Balance Error Scoring System (BESS) - minimally clinical important difference (MCID) is 3 points and MDC intra-rater 7.3 points.
Measured: Change from Baseline immediately after the intervention
Functional measurement - (SEBT)
Modified Star Excursion Balance Test (SEBT) - Minimally clinical important difference (MCID) is 3.5% difference between the two legs.
Measured: Change from Baseline immediately after the intervention
Functional measurement - Single Hop test
Single Hop test - MDC- score improved by 21.98 for women and 21.81 for man (as a % of leg length).
Measured: Change from Baseline immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start15 Sep 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- hyperbaric oxygen therapy (2ATA, 100% oxygen) vs. sham (1.2ATA, 21% oxygen)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Efrati, Assaf-Harofeh Medical Center
- Investigators
- Shai a Efrati, MD, Principal investigator, Asaf-Harofhe MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493851
- Sponsor's protocol ID
- 0166-23
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyperbaric Oxygen Therapy (HBOT) for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction (ACLR): a Prospective, Randomized Control Study.
- ClinicalTrials.gov ID
- NCT06493851
- Acronym / sponsor ID
- 0166-23
- Keywords
- hyperbaric oxygen therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- hyperbaric oxygen therapy (2ATA, 100% oxygen) vs. sham (1.2ATA, 21% oxygen)
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen therapy (HBOT) active treatment | Active comparator | Device: hyperbaric oxygen therapyThe 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. |
| hyperbaric oxygen therapy (HBOT) Sham treatment | Sham comparator | Device: hyperbaric oxygen therapyThe sham HBOT protocol consists of 6 weeks protocol including 5 daily sham HBOT sessions per week (total of 30), each session includes breathing 21% oxygen by mask in a sham multiplace chamber. Sham pressure will go up to 1.2 ATA during the first five minutes of the session (to stimulate the pressure sensation in the ears), and then decrease during the next 5 minutes to 1.03 ATA for 90 minutes with 5-minute air breaks every 20 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygen therapyThe 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. | Device | hyperbaric oxygen therapy (HBOT) Sham treatment, hyperbaric oxygen therapy (HBOT) active treatment |
Primary outcome
International Knee Documentation Committee
Time frame: Change from Baseline immediately after the intervention
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).
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Interventions to Enhance Quadriceps Output After ACLR
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shai a Efrati, MD principal investigator
Asaf-Harofhe MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen therapy in people with Anterior Cruciate Ligament Reconstruction, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shai a Efrati, MD (972549212866, efratishai@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (time frame: Change from Baseline immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.