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.

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

ACL Injury

Pain

Magnetic Field Exposure

Articular cartilage, similarly to bone tissue, has a high sensitivity to physical stimuli and
      it has been shown that these are able to significantly modify the cartilage metabolism. There
      are several methods for applying a physical stimulus to articular cartilage: direct current,
      pulsed electromagnetic fields, electric fields and ultrasound. In vitro, all techniques have
      been shown to influence the metabolism of isolated chondrocytes. In vivo and in the clinic,
      the use of the biophysical stimulus for the treatment of the joint must respond to the need
      to treat the articular cartilage in its total extension and thickness, in addition to
      involving the joint structures, for example meniscus, ligaments, synovial membrane up to to
      the subchondral bone.

      To date, these problems have been solved exclusively with the use of specific pulsed
      electromagnetic fields I-ONE®, as well demonstrated in the CRES study (Cartilage Repair and
      Electromagnetic Stimulation). In vitro, I-ONE® therapy produces a significant increase both
      in the proliferation of chondrocytes in the presence of Insulin growth factors- 1 (IGF-1),
      and in the synthesis of proteoglycans, also in the presence of inflammatory phenomena in the
      breeding ground, such as Interleukin 1B (IL-1B).

      In vitro studies on neutrophils, synoviocytes and chondrocytes have shown that I-ONE® therapy
      increases the availability of adenosine A2A receptors and, acting as chondroprotective drugs,
      reduces tissue damage due to the inflammatory response. These results have been demonstrated
      in animal models of osteoarthritis where, stimulation with I-ONE® therapy led to a reduction
      in the progression of osteoarthritic knee injuries. In sheep undergoing osteochondral
      transplantation, I-ONE® therapy has been able to favor the formation of new subchondral
      tissue, decreasing the areas of resorption and avoiding its complete resorption. A high
      synthesis of anabolic factors, such as Transforming growth factor beta (TGF-β), and an
      inhibition of the synthesis of pro-inflammatory cytokines such as the Tumor necrosis factor
      alfa (TNF-α) and Interleukin 1 beta (IL-1β) have been observed as evidence of an anabolic and
      trophic effect. In rabbits subjected to osteochondral lesions, I-ONE® therapy has proven
      effective in significantly improving the quality of both bone and cartilage regenerated
      tissue in osteochondral defects in the presence of collagen scaffolds and Mesenchymal Stem
      Cells (MSCs). MSCs have the potential to differentiate into a chondrocyte phenotype however
      the presence of pro-inflammatory cytokines in particular IL-1β is able to inhibit
      chondrogenesis.

      The anti-inflammatory activity of I-ONE® therapy effectively counteracted the degenerative
      effect of IL-1β by significantly improving cartilage regeneration compared to unstimulated
      lesions. This explains, even in vivo, the anti-degenerative, reparative and anti-inflammatory
      effect of treatment with I-ONE® therapy. In the clinical practice, I-ONE® therapy is able to
      prevent and/or slow down the degenerative phenomena that follow surgical operations. The
      latter result has been demonstrated both in patients undergoing anterior cruciate ligament
      reconstruction, and in patients with cartilage lesions treated with arthroscopic
      microfractures, in patients undergoing ONE STEP method with bone marrow concentrate and
      scaffold, and in patients undergoing total knee prosthesis with or without patellar
      resurfacing. All clinical studies have shown a reduction in NSAID intake and an anticipated
      functional recovery time in patients treated with I-ONE® therapy compared to those belonging
      to the non-treatment group. Also in the conservative treatment of joint pathologies, such as
      spontaneous osteonecrosis and knee osteoarthritis in the initial stagE I-ONE® therapy has
      proven effective in reducing the bone area marrow edema and in improving the functional
      recovery of the joint. Both in conservative and post-surgical treatment, the results were
      maintained even in the long term (follow-up 2 and 3 years after the treatment).

      Similar results have been found after treatment with I-ONE® therapy in patients with
      patello-femoral pain, a frequent pathology in sports, especially in women, whose
      etiopathogenesis is controversial and attributable to several factors, including a
      malalignment of the joint, a dysplasia of the patella or of the femoral trochlea. The
      anterior knee pain, which accompanies this pathology, can become chronic over time and become
      highly limiting for sports. I-ONE® therapy has proven effective in promoting joint function,
      resolving painful symptoms and promoting a rapid return to sports, maintaining the result
      over a year. I-ONE® is an easy-to-use therapy that eliminates the possible side effects that
      characterize drug therapy and its use is well accepted by patients. Since cartilage
      degeneration is an irreversible process, it is essential to intervene early with an effective
      chondroprotective treatment, which is able to maintain an intact cartilage in the long run
      while also preserving the quality of the subchondral bone tissue (of fundamental importance
      for the survival of the articular cartilage).

      In conclusion, the control of the joint microenvironment, by means of a non-invasive method,
      such as the biophysical stimulus, constitutes an important therapeutic possibility, which
      assumes a great importance in the presence of osteo-cartilaginous pain in the knee. In about
      70% of the lesions of the anterior cruciate ligament (ACL), the presence of trabecular
      microfractures due to the impact of the subchondral bone, called bone bruises, is associated.
      These are characterized by the presence of hemorrhage, edema, necrosis and fibrosis: they are
      most frequently located in the external compartment of the knee (most often in the lateral
      femoral condyle) and associated with intense pain (accentuated by the weight-bearing). These
      lesions tend to reabsorb very slowly and cause intense pain especially during the
      post-operative period in ACL reconstruction, with limitation and lengthening of recovery
      times. This is mainly due to the difficulty of weight-bearing during the first post-operative
      month.

      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.

      I-ONE® therapy will be initiated in the 15 days preceding the ACL reconstruction surgery and
      in the first 60 days following the surgery, only in the treatment group. The control group
      will not be treated with I-ONE® devices (no-treatment). Paracetamol 1000 mg will be supplied
      to both groups, to be taken for pain control as per normal clinical practice.Drugs and I-ONE®
      devices will be delivered to the patient on the day of the pre-hospitalization visit which
      takes place routinely 15 days before the surgery. Clinical assessments using rating scales
      will be performed in both groups on the day of the pre-hospitalization visit, immediately
      before ACL reconstruction and during outpatient visit at 1, 2, 4, 12 and 24 months after ACL
      reconstruction. Magnetic resonance imaging will be performed 2, 4 and 12 months after surgery
      to highlight both the integration of the pro-ACL graft and the reduction of the bone bruise
      area. In particular, to quantify the resolution of the bone bruise area expected in the
      treatment group, the magnetic resonance performed 2 months after surgery will be used.

I-ONE® therapy

Anti-inflammatory drug

Evaluation of the Effect of Biophysical Stimulation With Pulsed Electromagnetic Fields on Intraspongious Bone Edema in Anterior Cruciate Ligament Reconstruction

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.

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).

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

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.

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

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.

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

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

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