Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique
Arthrex, Inc.
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).
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 SB…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- 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 usin…
Interventions
- Combination ProductIntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion
Locations (5)
- University of Colorado Sports MedicineDenver, Colorado
- Andrews Research and Education FoundationGulf Breeze, Florida
- TidalHealth Peninsula Regional, Inc.Salisbury, Maryland
- The Ohio State UniversityColumbus, Ohio
- Allegheny-Singer Research InstitutePittsburgh, Pennsylvania