Effect of Biophysical Stimulation on Intraspongious Bone Edema in Anterior Cruciate Ligament Reco… (NCT04255407) | Clinical Trial Compass
CompletedNot Applicable
Effect of Biophysical Stimulation on Intraspongious Bone Edema in Anterior Cruciate Ligament Reconstruction
Italy66 participantsStarted 2017-11-20
Plain-language summary
The following study has as main objective to evaluate whether the use of I-ONE® therapy can reduce post-operative pain thanks to the modulation of inflammation in patients with bone bruise on the knee after anterior cruciate ligament (ACL) injury if applied 15 days before and 60 days after ACL reconstruction surgery for 4 hours a day compared to a control group (no-treatment). Both groups will be able to take anti-inflammatory drugs for pain control as per normal clinical practice.
The secondary objective of the study are: quantify the reduction in the size of the bone bruise area, improving the level of knee function and the amount of anti-inflammatory drugs used in the aforementioned patients in the postoperative period compared to a control group.
Who can participate
Age range
15 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients completely sane and lucid
* acute lesion of the acl (date of trauma not exceeding 21 days)
* presence of bone bruise diagnosed by magnetic resonance imagine (diagnosed as presence of a hyperintense signal area at the subchondral bone level in the fast spin echo T2 scans with fat saturation or STIR (short tau inversion recovery)
Exclusion Criteria:
* patients who have undergone previous surgery on the same knee or lower limb
* patients with previous cartilage lesions of the affected knee
* patients with major axial deviations of the knee (varus or valgus alignment \> 10°)
* patients who are taking cortisone therapies, use steroids, abuse alcohol
* menopausal women
* obesity (BMI\> 30 Kg / m²)
* ongoing infections
* patients with rheumatoid arthritis, autoimmune diseases, systemic diseases, neoplasms
* reduced motility of the knee (active flexion equal or less than 90 ° before surgery)
* chronic rupture of the ACL (due to an injury of more than 21 days)
* 3rd grade medial collateral ligament rupture
* Grade 3 or 4 osteonecrosis according to the International Cartilage Repair Society (ICRS) classification criteria
* previous total meniscectomy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analogue Scale
Timeframe: 24 months
2
Objective evaluation of the International Knee Documentation Committee
Timeframe: 24 months
3
Level of Tegner activity
Timeframe: 24 months
4
Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis.
Timeframe: 24 months
5
Monitoring of the intake of anti-inflammatory drugs