SCIENTIFIC EVIDENCE

BIOSTIM^®

In a retrospective study conducted at the Trauma Centre of San Carlos Hospital in Madrid, 57 patients with pseudarthrosis of the tibia were operated with intramedullary nailing. 22 of the 57 patients were stimulated with Biostim^® postoperatively, while the other 35 were evaluated as a control group. Stimulated patients recovered on average two months earlier than those in the control group. The percentage of cured patients was also significantly higher in the stimulated group.

A randomised, double-blind trial conducted at the Rizzoli Orthopaedic Institute in Bologna enrolled 65 patients (mean age 69 years) with femoral neck fracture treated by percutaneous synthesis with canulated screws within three days of injury. There were 30 patients in the active group and 35 in the placebo group. Biophysical stimulation with Biostim^® was started one week after surgery for eight hours a day for 90 days. At 90 days, the cure rate was significantly higher in the active group compared to the placebo group.

A randomised double-blind trial conducted at the Orthopaedics and Traumatology Unit of the Scandiano Hospital (RE) enrolled 40 patients undergoing tibia osteotomy (20 in the active group and 20 in the placebo group). Biophysical stimulation with Biostim® was started at three days after surgery for eight hours a day for 60 days. At 60 days, most of the stimulated patients were cured, compared to only 26% in the placebo group.

A randomised double-blind trial conducted at the Rizzoli Orthopaedic Institute in Bologna enrolled 83 patients undergoing massive bone grafting after resection for neoplastic diseases (40 patients in the active group and 43 in the placebo group). Biophysical stimulation with Biostim® was started within seven days of surgery for eight hours a day until healing. Stimulated patients who did not receive post-surgical chemotherapy achieved recovery in a shorter time (40%) than the placebo group.

OSTEOSPINE^®

A prospective observational study was conducted on 24 patients with multiple vertebral fractures treated conservatively at Bari Hospital. Half the patients were stimulated with OsteoSpine^® therapy (eight hours a day for 90 days), while the other half served as a control group. The study demonstrated the effectiveness of OsteoSpine^®  therapy in controlling acute and chronic pain. In patients treated with OsteoSpine^® therapy, the following benefits were obtained:

• significant reduction of pain already after the first month of treatment, a result achieved by patients in the control group only after 90 days.
• reduction in the resorption time of bone edema.
• early healing of fractures with complete resolution of associated pain.

A randomised, double-blind trial conducted by the University of Ferrara evaluated 42 patients undergoing vertebral arthrodesis surgery. 17 of the 42 patients were stimulated with OsteoSpine^® therapy (eight hours a day for 90 days), while the other 25 were assigned to the placebo group and therefore used an inactive device. The trial showed that patients stimulated with OsteoSpine^® therapy had less pain and significantly faster and more complete functional recovery than patients in the placebo group after spinal stabilisation surgery.

Patient underwent vertebroplasty in D12, suffering a D11 fracture after a few months. After 60 days of OsteoSpine^® therapy, a complete resolution of the edema in D11 and a significant regression of the edema in D12 were observed on an MRI scan. The pain completely disappeared and the patient returned to normal daily activities.

I-ONE^®

A randomised trial conducted at La Sapienza University in Rome evaluated 32 patients with symptomatic knee bone edema. Half the patients were stimulated with I-ONE^® therapy (four hours a day for 90 days), while the other half were evaluated as a control group. The trial presented at the American Academy of Orthopaedic Surgeons conference demonstrated the efficacy of I-ONE^® therapy in promoting the resorption of knee bone edema even in the presence of associated cartilage lesions.

A prospective study conducted in Milan at O.A.S.I. Bioresearch Foundation evaluated 22 patients with initial symptomatic knee osteoarthritis (Grade 1-2 according to the Kellgren and Lawrence system). The study was published in the influential journal ‘Cartilage’. Patients underwent a cycle of I-ONE^® therapy (four hours a day for 45 days), which effectively resolved their pain symptoms, promoted functional recovery and improved their quality of life. Patients resumed daily and sporting activities without pain.

A recent study conducted at the Civil Hospitals in Brescia on patients suffering from wrist algodystrophy has shown how I-ONE^® therapy significantly reduces swelling and joint pain after just one month of treatment, with a consequent increase in wrist and finger mobilisation during physiotherapy sessions.

The clinical use of I-ONE^®  therapy in the treatment of algodystrophy has recently been included in the Guidelines of the Italian Society of Hand Surgery and in those of the Tuscany Region.

A prospective study conducted at the Rizzoli Orthopaedic Institute in Bologna evaluated the efficacy of I-ONE^®  therapy in 28 symptomatic patients suffering from spontaneous osteonecrosis of the knee (SONK) at the initial Koshino I stage. I-ONE^® therapy (six hours a day for 90 days) resolved pain symptoms, increased joint function and reduced the area of subchondral edema by 85%. Two years after treatment with I-ONE^®  therapy, 86% of patients avoided knee replacement surgery.

BIOSTIM SPT^®

In a prospective study performed at the Orthopaedics and Traumatology Unit of Merano Hospital, 45 patients operated on uncemented prostheses (primary or revision) presenting pain at six months after surgery were evaluated. They were stimulated for 60 days with Biostim SPT®. 92% of patients compliant with the treatment protocol (60 days) resolved the pain problem. In contrast, patients who had done less than 30 days of therapy experienced a benefit in only 20% of cases.

In a retrospective study conducted at the Orthopaedic Clinic of the University of Ferrara, 76 patients with osteonecrosis of the femoral head stimulated with Biostim SPT® for six months were evaluated. At 24 months follow up, 94% of patients who were in the early stages of necrosis (FICAT I - II) at the start of therapy did not require hip replacement surgery.

In a randomised, double-blind trial performed at the Rizzoli Orthopaedic Institute in Bologna, 30 patients undergoing revision hip replacement were evaluated. 15 patients were stimulated with Biostim SPT® eight hours a day for 90 days, another 15 patients used a placebo device with the same protocol. At the end of therapy, their functional recovery was evaluated according to the Merle D’Aubigné score. 77% of patients in the active group showed complete functional recovery versus only 44% of patients in the placebo group.

The same patients underwent densitometry testing in the various Gruen zones, postoperatively and subsequently at 90 days. At the end of therapy, the DEXA examination shows significantly higher values in the stimulated group (93%) compared to the placebo group. The difference was more evident in the medial region, where it reached a level of statistical significance.

OSTEOBIT^®

A 30-year-old woman with a displaced fracture of the middle third of the carpal scaphoid. The surgical indication of synthesis with minimally invasive access is refused by the patient, who is then treated with modular brace + Osteobit® for six hours a day for two months. At the end of therapy, the patient recovered full joint function and achieved clinical and radiographic healing of the fracture.

Delayed union of a rugby player two months after surgical plate treatment. Start treatment with Osteobit® in combination with brace, six hours a day for three months. The athlete continues training during this period. The follow-up X-ray at the end of therapy shows the fracture fully healed.

In a prospective study conducted at the CTO Hospital in Rome, 30 patients presenting with pseudarthrosis in different skeletal districts were treated. They were stimulated with Osteobit® for a mean treatment time of nine weeks. 84% of patients achieved radiographic union.

I-ONE^® TPC

A randomised, double-blind trial conducted at Negrar Hospital in Verona recruited 31 patients undergoing knee arthroscopy for cartilage abrasions and/or perforations (cartilage tissue repair techniques). 19 of the 31 patients were stimulated with I-ONE^® TPC (four hours a day for 60 days), while the other 12 were treated with a placebo device. Patients in the I-ONE^® TPC group compared to those in the control group:

• Resolved post-surgical inflammation and associated pain early.
• Reduced use of anti-inflammatory drugs.
• Achieved better knee function over time, even three years after surgery.

Another randomised trial with control group conducted at the Rizzoli Orthopaedic Institute in Bologna on 30 patients with osteochondral lesions of the talus treated by transplantation of bone marrow-derived stem cells, confirmed the effectiveness of I-ONE^® TPC in resolving pain even two months after surgery and improved clinical outcome in the long term (Cadossi M et al. Foot&Ankle Int 2014).

A randomised trial conducted at Bari Hospital evaluated 30 patients undergoing total knee replacement surgery. 15 of the 30 patients were stimulated with I-ONE^® TPC (four hours a day for 60 days), while the other 15 were evaluated as a control group. The trial demonstrated the effectiveness of I-ONE^® TPC in relieving pain, reducing joint effusion and recovery time, and improving the function of the prosthetic knee over time.

In a randomised trial conducted at the Città di Parma Treatment Centre, 33 patients underwent total knee arthroplasty surgery. 16 of the 33 patients were stimulated with I-ONE^® TPC (four hours a day for 60 days), while the other 17 were evaluated as a control group. The results of the trial showed that three years after surgery, only 7% of patients in the group stimulated with I-ONE^® TPC complained of knee pain, compared to 33% of patients in the control group.

A major Italian multi-centre, randomised, double-blind trial coordinated by the University of Pavia was conducted on 60 patients undergoing anterior cruciate ligament reconstruction associated with meniscectomy in a subgroup of 29 patients. 31 patients were stimulated with I-ONE^® TPC for four hours a day for 60 days (active group), while the other 29 were treated with a placebo device. In the subgroup of patients who also underwent meniscectomy, 15 patients were included in the active group and 14 in the placebo group. Patients in the active group significantly reduced their use of pain medication and regained full joint function in a third of the time compared to those treated with the placebo device.

FAST^®

A randomised, double-blind trial from the Department of Orthopaedics at the University of Texas in San Antonio evaluated the results of using biophysical stimulation with low-intensity ultrasound in recent tibia fractures: 67 patients with closed or exposed diaphyseal fracture (Grade I) treated conservatively. 33 patients were stimulated with an active device and 34 with a placebo for a period of 20 weeks, 20 minutes per day. The trial reported a reduction in mean clinical and radiographic healing time of 38% in stimulated patients.

A 45-year-old man with infected pseudarthrosis of the tibia (Staphylococcus aureus) seven months after trauma treated with intramedullary nail. Start therapy with FAST®, 20 minutes a day combined with antibiotic therapy. After four months of therapy, the radiographic investigation shows bone callus formation. Radiographs at 18 months after trauma after nail removal.

A 57-year-old man with post-traumatic pseudarthrosis of the forearm treated with an Ilizarov fixator for six months. After 60 days of FAST® therapy for 20 minutes a day, the patient achieved clinical and radiographic healing.