Subchondral Cyst
Conditions
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).
Detailed description
The study will be a prospective, multicenter, clinical study, enrolling both male and female patients. Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. IRB approval will be obtained by each participating institution. The primary outcome measure is adverse event evaluation to determine whether IOBP® can prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee.
Interventions
COMBINATION_PRODUCTIntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion
Sponsors
Arthrex, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of additional surgery into the target knee | 5 years | To evaluate if IOBP® procedure will prevent further surgical intervention (i.e., knee replacement surgery, HTO, or calcium phosphate stabilization of SBP) when used to treat symptomatic SBP of the knee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Scale (VAS) | Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op. | Patient reported pain scale using a 10 cm scale with a numeric rating of 0 to 10, with 0 |
| International Knee Documentation Committee Subjective Knee Evaluation Form | knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. | A patient-oriented questionnaire that assesses symptoms and function in daily living activities. The purpose of this study was to validate the IKDC Subjective Knee Form in a large patient population with various knee disorders. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op | A knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. |
| X-rays of the knee | 6 months and 1 year | Images include weight-bearing AP, 45 degree weight bearing PA, lateral and merchant views. Images taken to determine location and status of subchondral bone lesion. |
| MRI of the knee | 6 months and 1 year | Minimum 1.5 Tesla MRI (including coronal, axial, sagittal, lateral femur, and lateral tibial views). Image taken to determine location and status of subchondral bone lesion. |
Countries
United States
Contacts
Primary ContactJustin W Moss, DHSc
Backup ContactAlicia Ruiz, MS
Outcome results
None listed