Treatment of knee subchondral cysts using IOBP technique
Official title: Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique
Run by Arthrex, Inc. · NCT05314608 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Arthrex, Inc. Industry-sponsored |
| Locations | 5 sites (Denver, Colorado and 4 other locations) |
| Status | Recruiting |
| Started | November 17, 2021 |
| Main results expected | May 17, 2027 |
| Study ends | May 17, 2027 |
| Registry record updated | December 5, 2022 |
| Trial ID | NCT05314608 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-60 with symptomatic subchondral bone pathology in the knee who are scheduled for IOBP® surgery.
✕Probably not a fit
Patients with uncontrolled diabetes, recent lower extremity surgeries, or significant obesity may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies have not been widely reported, indicating a potential for novel findings.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.