Study of IntraOsseous BioPlasty Surgical Treatment for Knee Subchondral Bone Lesions in Adults Aged 18 to 60

What this Trial Is About

Researchers are evaluating the IntraOsseous BioPlasty4 IOBP4 surgical technique to treat subchondral bone pathology SBP in the knee. This prospective, multicenter clinical study includes both male and female patients aged 18 to 60 years who have symptomatic SBP that has not improved with conservative treatments. The main goal is to assess whether IOBP4 can prevent the need for additional knee surgeries such as knee replacement, high tibial osteotomy, or calcium phosphate stabilization over a five-year period. The study involves subjects receiving the IOBP4 procedure, which includes injecting a biologic mixture of bone marrow concentrate and allograft into the subchondral bone lesion of the knee. Participants are identified from the investigators patient population and must be scheduled for this surgical intervention. This observational study monitors patients over time to evaluate outcomes related to the treatment of SBP. Participants will undergo regular assessments including pain measurement using the Visual Analog Pain Scale at multiple time points from before surgery up to five years after. Knee function and symptoms will be evaluated using the International Knee Documentation Committee Subjective Knee Evaluation Form and the Knee Injury and Osteoarthritis Outcome Score KOOS. Imaging studies such as X-rays and MRI will be performed at six months and one year to monitor the knee condition. Safety monitoring focuses on adverse events and the need for further surgery during the five-year follow-up period.

Knee Related Subchondral Bone Lesions Treated With IOBP