Clinical Research Directory

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.