NCT05314608 Knee Related Subchondral Bone Lesions Treated With IOBP
| NCT ID | NCT05314608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Arthrex, Inc. |
| Condition | Subchondral Cyst |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-11-17 |
| Primary Completion | 2027-05-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-11-17 with a primary completion date of 2027-05-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP).
Eligibility 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
Contact & Investigator
Adam Anz
PRINCIPAL INVESTIGATOR
Andrews Research and Education Foundation
Frequently Asked Questions
Who can join the NCT05314608 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Subchondral Cyst. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05314608 currently recruiting?
Yes, NCT05314608 is actively recruiting participants. Contact the research team at justin.moss@arthrex.com for enrollment information.
Where is the NCT05314608 trial being conducted?
This trial is being conducted at Denver, United States, Gulf Breeze, United States, Salisbury, United States, Columbus, United States and 1 additional location.
Who is sponsoring the NCT05314608 clinical trial?
NCT05314608 is sponsored by Arthrex, Inc.. The principal investigator is Adam Anz at Andrews Research and Education Foundation. The trial plans to enroll 100 participants.