🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05314608
Recruiting Observational

Knee Related Subchondral Bone Lesions Treated With IOBP

NCT05314608 · tracked via the Priya Life Science USA tracker
Sponsor
Arthrex, Inc.
Phase
Observational
Started
2021-11-17
Last updated
2022-12-05

Condition(s) studied

Subchondral Cyst

Investigational drug(s) / intervention(s)

IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee

IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee: Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
University of Colorado Sports Medicine Denver Colorado Recruiting
Andrews Research and Education Foundation Gulf Breeze Florida Recruiting
TidalHealth Peninsula Regional, Inc. Salisbury Maryland Recruiting
The Ohio State University Columbus Ohio Recruiting
Allegheny-Singer Research Institute Pittsburgh Pennsylvania Recruiting

More Arthrex, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05314608 on ClinicalTrials.gov ↗ ← All trials in the USA