Clinical Research Directory

Extracorporeal Shock Wave Therapy in the Treatment of Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis

Bone marrow edema (BME) is a radiological finding characterized by increased fluid content and structural changes within the bone marrow. It most commonly affects weight-bearing joints such as the hip, knee, and ankle. Patients with BME may present with pain during activity or at rest, tenderness, swelling, joint effusion, and limitation of joint motion. Magnetic resonance imaging (MRI) is considered the gold standard for diagnosis. BME is commonly observed in patients with knee osteoarthritis (OA) and may be associated with increased pain, impaired joint function, and progression of structural joint damage. Therefore, recognition and treatment of BME may be clinically important in patients with knee OA. Treatment options for BME include conservative and surgical approaches. Standard conservative treatment generally includes activity and weight-bearing modification, analgesics and nonsteroidal anti-inflammatory drugs, and physical therapy modalities. Extracorporeal shock wave therapy (ESWT) is one of the non-invasive physical therapy options that can be added to standard conservative treatment. Surgical treatment, including core decompression, may be considered in patients who do not respond to conservative treatment. ESWT may exert beneficial effects by improving local blood flow, promoting angiogenesis, stimulating bone remodeling and regeneration, and providing analgesia. Previous studies in patients with knee-related BME have suggested that ESWT may reduce pain, improve functional outcomes, and decrease BME findings on MRI. Kang et al. reported more rapid improvements in pain, functional outcomes, and the MRI-detected area of BME within three months with ESWT compared with alendronate therapy. Sansone et al. found that ESWT resulted in greater reductions in pain and BME area, together with clinically meaningful improvement at three months, compared with conservative treatment consisting of unloading and analgesics. In a prospective randomized controlled trial, Gao et al. further showed that ESWT provided more favorable six-month outcomes in terms of pain, functional scores, and MRI-assessed BME area than intravenous prostacyclin combined with oral bisphosphonate therapy. Collectively, these findings suggest that ESWT may provide sustained clinical and radiological benefits in patients with knee BME. This study aims to investigate the effects of adding ESWT to standard conservative treatment in patients with knee osteoarthritis accompanied by bone marrow edema. Patients receiving active ESWT will be compared with those receiving sham ESWT in terms of pain, functional outcomes, patient satisfaction, and changes in bone marrow edema volume on MRI.

Functional Magnetic Stimulation (FMS) for Bone Marrow Edema in Athletes

This randomized controlled trial evaluates whether Functional Magnetic Stimulation (FMS) can provide additional benefits when combined with a structured physiotherapy rehabilitation program in athletes with MRI-confirmed tibial bone stress injury and associated bone marrow edema. A total of 40 athletes with Fredericson grade 2 or 3 lesions are allocated to either a combined intervention group receiving FMS plus rehabilitation or a control group receiving rehabilitation alone. The intervention period lasts four weeks. Participants in both groups follow the same load-based rehabilitation program, while those in the FMS group also receive eight 30-minute FMS sessions. Assessments are performed at baseline, after the four-week intervention, and at 16 weeks. The evaluated outcomes include activity-related tibial pain, lower-limb functional ability, MRI-measured bone marrow edema extent, and Fredericson MRI grade. The purpose of the study is to examine whether adding FMS to standardized rehabilitation leads to greater clinical, functional, and MRI-derived improvement compared with rehabilitation alone.

Subchondroplasty® Knee RCT

This is a multi-center, prospective, single-blinded, two-arm study, randomized to include approximately 134 subjects treated with Subchondroplasty (SCP) + Arthroscopy and 67 subjects with arthroscopy alone. The primary objective of this study is to demonstrate superiority of Subchondroplasty with arthroscopy compared to arthroscopy alone for treatment of Bone Marrow Lesions (BMLs) in the knee.

SCP Hip Outcomes Study

Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain, function, activity levels and patient satisfaction.

Focused Extracorporeal Shockwave Therapy for Knee Arthritis

Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are strongly associated with presence and severity of knee pain, structural deterioration, disease progression with an increased risk of total knee arthroplasty. OA-related BMLs may regress or resolve within 30 months which could be associated with long lasting disability. It has been reported that BMLs persist in the majority of knee OA patients. Different treatment strategies have been proposed including rest and protected weight-bearing, bisphosphonates, subchondroplasty and intraosseous orthobiologic injection. However, conservative treatment response takes a long time and other interventions may be considered invasive procedures that show varying results with several side effects. Focused extracorporeal shockwave therapy (f-ESWT) has been established as a safe non-invasive treatment with positive results in different bone disorders that share the same pathological features of BMLs. This is an exploratory, randomized-controlled, pilot study to determine the efficacy and safety of f-ESWT compared to the standard-of-care (analgesics and protected weight bearing) for the treatment of BMLs in patients with knee OA. Thirty subjects with knee OA who have history of knee pain at rest and during walking with the confirmed diagnosis of subchondral BML(s) on magnetic resonance imaging (MRI) despite at least 4 weeks of conservative treatment will be enrolled into this study. Subjects will receive a total of 4 sessions (at high energy level) over 4 consecutive weeks. Participants will be evaluated for adverse events and changes in pain intensity and knee function, using an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine") and; the Knee injury and Osteoarthritis Outcome Score, respectively. Subjects will be assessed with these outcome measures at baseline, 1 month, 2 months, 3 months, and 6 months after the treatment. MRI of the involved knee will be performed prior to treatment (baseline) and 3 months and 6 months after treatment.