Effect of Biophysical Stimulation on Intraspongious Bone Edema in Anterior Cruciate Ligament Reconstruction

• Status: Recruiting
• Trial end date: 2020-11-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Ortopedico Rizzoli
• Treatments: Anti-Inflammatory Agents

Criteria

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