Knee Related Subchondral Bone Lesions Treated With IOBP

Description

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).

Conditions

Subchondral Cyst

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Study Overview

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Study Details

Study overview

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).

Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique

Knee Related Subchondral Bone Lesions Treated With IOBP

Condition
Subchondral Cyst
Intervention / Treatment

-

Contacts and Locations

Denver

University of Colorado Sports Medicine, Denver, Colorado, United States, 80222

Gulf Breeze

Andrews Research and Education Foundation, Gulf Breeze, Florida, United States, 32561

Salisbury

TidalHealth Peninsula Regional, Inc., Salisbury, Maryland, United States, 21801

Columbus

The Ohio State University, Columbus, Ohio, United States, 43201

Pittsburgh

Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania, United States, 15212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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®
  • 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

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arthrex, Inc.,

Adam Anz, PRINCIPAL_INVESTIGATOR, Andrews Research and Education Foundation

Study Record Dates

2027-05-17