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

NCT04255407 | Completed

• 1 other identifier: PEMF-LCA
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ACL Injury; Pain; Magnetic Field Exposure

Keywords

bone bruise; pain; ACL reconstruction

Outcome Measures

Primary Outcomes (5)

• Visual Analogue Scale

  It is a straight line with one end (scorse 0) meaning no pain and the other end (score 10) meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.

  24 months

• Objective evaluation of the International Knee Documentation Committee

  The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). It's considered to be one of the most reliable outcome reporting tools in its category and was one of the instruments used in the popular MOON study. IKDC has been subjected to rigorous statistical evaluation and has proven to be a valid and responsive patient-reported outcome measure (PROM). 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).

  24 months

• Level of Tegner activity

  The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer

  24 months

• Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis.

  To quantify the reduction of the area affected by bone edema, a semi-quantitative scoring method for multi-feature, whole-organ evaluation of the knee in osteoarthritis (OA) based on magnetic resonance imaging (MRI) findings will be used. Subarticular bone marrow abnormality was defined as poorly marginated areas of increased signal intensity in the normally fatty epiphyseal marrow on fat-suppressed T2-weighted FSE images. It will be evaluated in 15 different regions subdivided by anatomical landmarks in the fully extended knee and was graded from 0 to 3 based on the extent of regional involvement: 0=none; 1=\<25% of the region; 2=25% to 50% of the region; 3=\>50% of the region.

  24 months

• Monitoring of the intake of anti-inflammatory drugs

  Patients will record in a diary all daily anti-inflammatory drug intake

  24 months

Study Arms (2)

I-ONE® group

EXPERIMENTAL

I-ONE® therapy will be initiated in the 15 days preceding the ACL reconstruction surgery and in the first 60 days following the surgery. Paracetamol 1000 mg will be supplied to both groups, to be taken for pain control as per normal clinical practice.

Device: I-ONE® therapy

Control group

PLACEBO COMPARATOR

Patients will not be treated with I-ONE®. Pain will be treated with common NSAID and Paracetamol.

Drug: Anti-inflammatory drug

Interventions

I-ONE® therapy DEVICE

I-ONE® therapy will be used in patients with bone bruise on the knee after anterior cruciate ligament (ACL) injury 15 days before and 60 days after ACL reconstruction surgery for 4 hours a day compared to a control group (no-treatment).

Also known as: I-ONE® IGEA

I-ONE® group

Anti-inflammatory drug DRUG

Pain before and after ACL reconstruction will be managed with common anti-inflammatory drugs (Paracetamol)

Control group

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• rd grade medial collateral ligament rupture
• Grade 3 or 4 osteonecrosis according to the International Cartilage Repair Society (ICRS) classification criteria
• previous total meniscectomy

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (5)

• Papalia R, Torre G, Vasta S, Zampogna B, Pedersen DR, Denaro V, Amendola A. Bone bruises in anterior cruciate ligament injured knee and long-term outcomes. A review of the evidence. Open Access J Sports Med. 2015 Feb 18;6:37-48. doi: 10.2147/OAJSM.S75345. eCollection 2015.

  PMID: 25733936 RESULT

• Massari L, Benazzo F, De Mattei M, Setti S, Fini M; CRES Study Group. Effects of electrical physical stimuli on articular cartilage. J Bone Joint Surg Am. 2007 Oct;89 Suppl 3:152-61. doi: 10.2106/JBJS.G.00581. No abstract available.

  PMID: 17908881 RESULT

• Zorzi C, Dall'Oca C, Cadossi R, Setti S. Effects of pulsed electromagnetic fields on patients' recovery after arthroscopic surgery: prospective, randomized and double-blind study. Knee Surg Sports Traumatol Arthrosc. 2007 Jul;15(7):830-4. doi: 10.1007/s00167-007-0298-8. Epub 2007 Feb 28.

  PMID: 17333120 RESULT

• Moretti B, Notarnicola A, Moretti L, Setti S, De Terlizzi F, Pesce V, Patella V. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study. BMC Musculoskelet Disord. 2012 Jun 6;13:88. doi: 10.1186/1471-2474-13-88.

  PMID: 22672794 RESULT

• Adravanti P, Nicoletti S, Setti S, Ampollini A, de Girolamo L. Effect of pulsed electromagnetic field therapy in patients undergoing total knee arthroplasty: a randomised controlled trial. Int Orthop. 2014 Feb;38(2):397-403. doi: 10.1007/s00264-013-2216-7. Epub 2013 Dec 20.

  PMID: 24352823 RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Pain

Interventions

Anti-Inflammatory Agents

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Stefano Zaffagnini, MD, PhD

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: November 20, 2017
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)