Using hyperbaric oxygen therapy to speed up recovery after ACL surgery
The Effect of Hyperbaric Oxygen Therapy (HBOT) for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction (ACLR): a Prospective, Randomized Control Study.
This study is testing if hyperbaric oxygen therapy can help athletes recover faster after ACL surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Locations | 1 site (Zrifin) |
| Trial ID | NCT06493851 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of hyperbaric oxygen therapy (HBOT) in accelerating recovery following anterior cruciate ligament reconstruction (ACLR). ACL injuries are common among athletes, and the recovery process can take around eight months. The research aims to determine if HBOT can enhance healing and reduce recovery time based on previous findings in animal studies and limited human trials. Participants will undergo HBOT as part of their rehabilitation to assess improvements in recovery metrics.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-45 who have sustained an anterior cruciate ligament tear requiring reconstruction.
Not a fit: Patients with additional injuries, previous knee surgeries, or certain medical conditions such as active malignancy or chest pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce recovery time for athletes after ACL surgery, allowing for a quicker return to sports.
How similar studies have performed: Previous studies on hyperbaric oxygen therapy for other ligament injuries have shown positive outcomes, suggesting potential for success in this study as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects willing and able to read, understand and sign an informed consent 2. Age 18-45 3. Anterior cruciate ligament tear for reconstruction (with or without meniscal repair). Exclusion Criteria: 1. Inability to attend scheduled clinic visits and/or comply with the study protocol 2. Additional injury 3. An inability to perform MRI. 4. Active malignancy 5. Chest pathology incompatible with pressure changes (including active asthma) 6. Ear or sinus pathology incompatible with pressure changes 7. History of epilepsy 8. Claustrophobia 9. Previous knee surgery 10. Participation in another study
Where this trial is running
Zrifin
- The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh) — Zrifin, Israel (Recruiting)
Study contacts
- Principal investigator: Shai a Efrati, MD — Asaf-Harofhe MC
- Study coordinator: Shai a Efrati, MD
- Email: efratishai@outlook.com
- Phone: 972549212866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.