RECRUITING

Knee Related Subchondral Bone Lesions Treated With IOBP

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Conditions

Subchondral Cyst

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2021-11-17
Study Completion:2027-05-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05314608

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to read, understand, sign and complete informed consent
  2. 2. Male or female subject between the ages of 18-60 years
  3. 3. Subject has had pain for greater than three months
  4. 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. 5. Subject has stable ligaments
  6. 6. Subject has neutral alignment (max 5° varus or valgus)
  7. 7. Subject has a VAS score greater than or equal to five
  8. 8. Subject is scheduled to undergo surgical intervention using IOBP®
  1. 1. Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent
  2. 2. Subject has had lower extremity surgery within six months
  3. 3. Subject has had more than two prior surgical procedures in the operative leg
  4. 4. Subject has a neuromuscular condition
  5. 5. Subject has a current infection
  6. 6. Subject has a BMI \>35
  7. 7. Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis
  8. 8. Subject has joint surface collapse in late stage avascular necrosis
  9. 9. Subject has majority of pain associated with alternate conditions
  10. 10. Subject has had subchondral bone pathology caused by acute trauma
  11. 11. Subject is not neurologically intact.
  12. 12. Subject has history of invasive malignancy (except non-melanoma skin cancer)
  13. 13. Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity)
  14. 14. Subject has an active substance abuse problem
  15. 15. Subject is currently taking narcotic pain medication
  16. 16. Subject is pregnant or planning to become pregnant
  17. 17. Subject is on worker's compensation
  18. 18. Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body
  19. 19. Inability to complete study requirements and follow-up visits
  20. 20. Subject that has a bone marrow aspiration that does not meet 60cc

Contacts and Locations

Study Contact

Justin W Moss, DHSc
CONTACT
770 584 4972
justin.moss@arthrex.com
Alicia Ruiz, MS
CONTACT
1 (800) 933-7001

Principal Investigator

Adam Anz
PRINCIPAL_INVESTIGATOR
Andrews Research and Education Foundation

Study Locations (Sites)

University of Colorado Sports Medicine
Denver, Colorado, 80222
United States
Andrews Research and Education Foundation
Gulf Breeze, Florida, 32561
United States
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21801
United States
The Ohio State University
Columbus, Ohio, 43201
United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
United States

Collaborators and Investigators

Sponsor: Arthrex, Inc.

  • Adam Anz, PRINCIPAL_INVESTIGATOR, Andrews Research and Education Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-17
Study Completion Date2027-05-17

Study Record Updates

Study Start Date2021-11-17
Study Completion Date2027-05-17

Terms related to this study

Additional Relevant MeSH Terms

  • Subchondral Cyst