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

NCT06493851 | Recruiting

• 1 other identifier: 0166-23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

hyperbaric oxygen therapy

Outcome Measures

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).

  Change from Baseline immediately after the intervention

Secondary Outcomes (12)

• Knee MRI

  Change from Baseline immediately after the intervention

• Laxity ligament test

  Change from Baseline immediately after the intervention

• physical measurement - ROM

  Change from Baseline immediately after the intervention

• physical measurement - Edema

  Change from Baseline immediately after the intervention

• physical measurement - Vas for pain

  Change from Baseline immediately after the intervention

Study Arms (2)

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.

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.

Device: hyperbaric oxygen therapy

Interventions

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.

hyperbaric oxygen therapy (HBOT) Sham treatment; hyperbaric oxygen therapy (HBOT) active treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

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

Zrifin, 70300, Israel

RECRUITING

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Shai a Efrati, MD

  Asaf-Harofhe MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shai a Efrati, MD

CONTACT

972549212866; efratishai@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: hyperbaric oxygen therapy (2ATA, 100% oxygen) vs. sham (1.2ATA, 21% oxygen)

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

IL (1)