Treatment of knee subchondral cysts using IOBP technique
Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique
This study is testing a new knee surgery called IntraOsseous BioPlasty® to see if it can help people aged 18-60 with ongoing knee pain avoid needing more surgery, like a knee replacement.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Arthrex, Inc. Industry-sponsored |
| Locations | 5 sites (Denver, Colorado and 4 other locations) |
| Trial ID | NCT05314608 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical and patient-reported outcomes of patients undergoing the IntraOsseous BioPlasty® (IOBP®) surgical technique for treating symptomatic subchondral bone pathology (SBP) in the knee. It will enroll male and female patients aged 18-60 who have experienced knee pain for over three months and have not responded to conservative treatments. The study will assess the effectiveness of IOBP® in preventing the need for further surgical interventions, such as knee replacement surgery. Each participating institution will obtain IRB approval to ensure ethical standards are met.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with symptomatic subchondral bone pathology in the knee who are scheduled for IOBP® surgery.
Not a fit: Patients with uncontrolled diabetes, recent lower extremity surgeries, or significant obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for more invasive knee surgeries in patients with subchondral bone lesions.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating a potential for novel findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Able to read, understand, sign and complete informed consent 2. Male or female subject between the ages of 18-60 years 3. Subject has had pain for greater than three months 4. Subjects with single SBP in tibia or femur confirmed by minimum 1.5T MRI (including coronal, axial, sagittal, lateral femur, and lateral tibia views) and are candidates for an IOBP® procedure 5. Subject has stable ligaments 6. Subject has neutral alignment (max 5° varus or valgus) 7. Subject has a VAS score greater than or equal to five 8. Subject is scheduled to undergo surgical intervention using IOBP® Exclusion Criteria: 1. Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent 2. Subject has had lower extremity surgery within six months 3. Subject has had more than two prior surgical procedures in the operative leg 4. Subject has a neuromuscular condition 5. Subject has a current infection 6. Subject has a BMI \>35 7. Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis 8. Subject has joint surface collapse in late stage avascular necrosis 9. Subject has majority of pain associated with alternate conditions 10. Subject has had subchondral bone pathology caused by acute trauma 11. Subject is not neurologically intact. 12. Subject has history of invasive malignancy (except non-melanoma skin cancer) 13. Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity) 14. Subject has an active substance abuse problem 15. Subject is currently taking narcotic pain medication 16. Subject is pregnant or planning to become pregnant 17. Subject is on worker's compensation 18. Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body 19. Inability to complete study requirements and follow-up visits 20. Subject that has a bone marrow aspiration that does not meet 60cc
Where this trial is running
Denver, Colorado and 4 other locations
- University of Colorado Sports Medicine — Denver, Colorado, United States (Recruiting)
- Andrews Research and Education Foundation — Gulf Breeze, Florida, United States (Recruiting)
- TidalHealth Peninsula Regional, Inc. — Salisbury, Maryland, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Adam Anz — Andrews Research and Education Foundation
- Study coordinator: Justin W Moss, DHSc
- Email: justin.moss@arthrex.com
- Phone: 770 584 4972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.