Subchondroplasty for the Treatment of Knee Pain Associated with Tibial Bone Marrow Lesions and Osteoarthritis

Full Title of Study

Prospective Efficacy Evaluation of Subchondroplasty for the Treatment of Knee Pain Associated with Tibial Bone Marrow Lesions and Osteoarthritis. (S#11-02420)

Purpose of Study

To determin the effectiveness of treating knee pain with subchondroplasty (SCP), a treatment that attempts to heal subchondral ("underneath the cartilage") bone marrow lesions (BMLs) in the knee. Bone marrow lesions are abnormal areas of bone in the knee joint that have been shown to be linked to knee pain. 

Basic Inclusion Criteria (requirements for being included in study

  • 40 to 75 years of age
  • Subject has experienced pain in knee for at least 3 months
  • Presence of bone marrow lesion (BML) is confirmed by MRI

Basic Exclusion Criteria (reasons for being excluded from study)

  • Subject is diagnosed with severe OA
  • Subject is insulin dependent
  • Presence of bone marrow lesion (BML) exists in more than one knee compartment in the tibia (shown on MRI)
  • Presence of BML exists in the femur (shown on MRI)

Study Visit Requirements

Once the study doctor has determined the location and severity of the bone marrow lesion, and you have agreed to participate in the study by signing this informed consent document, you will be enrolled in the study. Prior to your surgery, you will be asked to undergo a clinical orthopedic evaluation (standard care). You will fill out questionnaires on the state of your knee pain and how well you can function. These questionnaires are part of the study. After your surgery you will need to follow your surgeon's instructions. You will receive a postoperative rehabilitation recommendation from your study doctor which will include 1-3 weeks of crutches, a minimum of 6 weeks of bracing and/or exercises. This post-operative care is standard for the Subchondroplasty procedure whether you take part in the study or not. You will be required to go back for additional visits to the doctor who performed the surgery so more can be learned about how the SCP works on your knee. You will be expected to return to the doctor's office 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months after you have been treated. 

Principal Investigator

Thomas Youm, MD

Answers to frequently asked questions (FAQs) about clinical trials

For more information about enrolling in this study, please contact Cara Fontaine, or 212-598-6521