RecruitingNCT05314608
Knee Related Subchondral Bone Lesions Treated With IOBP
Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique
Sponsor
Arthrex, Inc.
Enrollment
100 participants
Start Date
Nov 17, 2021
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 YearsMax Age: 60 Years
Inclusion Criteria8
- Able to read, understand, sign and complete informed consent
- Male or female subject between the ages of 18-60 years
- Subject has had pain for greater than three months
- 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
- Subject has stable ligaments
- Subject has neutral alignment (max 5° varus or valgus)
- Subject has a VAS score greater than or equal to five
- Subject is scheduled to undergo surgical intervention using IOBP®
Exclusion Criteria20
- Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent
- Subject has had lower extremity surgery within six months
- Subject has had more than two prior surgical procedures in the operative leg
- Subject has a neuromuscular condition
- Subject has a current infection
- Subject has a BMI >35
- Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis
- Subject has joint surface collapse in late stage avascular necrosis
- Subject has majority of pain associated with alternate conditions
- Subject has had subchondral bone pathology caused by acute trauma
- Subject is not neurologically intact.
- Subject has history of invasive malignancy (except non-melanoma skin cancer)
- Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity)
- Subject has an active substance abuse problem
- Subject is currently taking narcotic pain medication
- Subject is pregnant or planning to become pregnant
- Subject is on worker's compensation
- Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body
- Inability to complete study requirements and follow-up visits
- Subject that has a bone marrow aspiration that does not meet 60cc
Interested in this trial?
Get notified about updates and connect with the research team.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05314608