Actively Recruiting
Knee Related Subchondral Bone Lesions Treated With IOBP
Led by Arthrex, Inc. · Updated on 2022-12-05
100
Participants Needed
5
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Knee Related Subchondral Bone Lesions Treated With IOBP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and are candidates for an IOBP4 procedure
- Subject has stable ligaments
- Subject has neutral alignment (max 56 varus or valgus)
- Subject has a VAS score greater than or equal to five
- Subject is scheduled to undergo surgical intervention using IOBP4
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Colorado Sports Medicine
Denver, Colorado, United States, 80222
Actively Recruiting
2
Andrews Research and Education Foundation
Gulf Breeze, Florida, United States, 32561
Actively Recruiting
3
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, United States, 21801
Actively Recruiting
4
The Ohio State University
Columbus, Ohio, United States, 43201
Actively Recruiting
5
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
Research Team
J
Justin W Moss, DHSc
CONTACT
A
Alicia Ruiz, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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