Status:
RECRUITING
Knee Related Subchondral Bone Lesions Treated With IOBP
Lead Sponsor:
Arthrex, Inc.
Conditions:
Subchondral Cyst
Eligibility:
All Genders
18-60 years
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...
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® p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 17 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05314608
Start Date
November 17 2021
End Date
May 17 2027
Last Update
December 5 2022
Active Locations (5)
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1
University of Colorado Sports Medicine
Denver, Colorado, United States, 80222
2
Andrews Research and Education Foundation
Gulf Breeze, Florida, United States, 32561
3
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, United States, 21801
4
The Ohio State University
Columbus, Ohio, United States, 43201