Knee Related Subchondral Bone Lesions Treated With IOBP
NCT ID: NCT05314608
Last Updated: 2022-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2021-11-17
2027-05-17
Brief Summary
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Detailed Description
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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 SBP of the knee.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects with subchondral bone pathology
Subjects with subchondral bone pathology
IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion
Interventions
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IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion
Eligibility Criteria
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Inclusion Criteria
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 using IOBP®
Exclusion Criteria
2. Subject has had lower extremity surgery within six months
3. Subject has had more than two prior surgical procedures in the operative leg
4. Subject has a neuromuscular condition
5. Subject has a current infection
6. Subject has a BMI \>35
7. Subject has subchondral bone collapse or Kellgren Lawrence grade IV osteoarthritis
8. Subject has joint surface collapse in late stage avascular necrosis
9. Subject has majority of pain associated with alternate conditions
10. Subject has had subchondral bone pathology caused by acute trauma
11. Subject is not neurologically intact.
12. Subject has history of invasive malignancy (except non-melanoma skin cancer)
13. Subject that has a planned or scheduled additional surgery within the course of the study (lower extremity)
14. Subject has an active substance abuse problem
15. Subject is currently taking narcotic pain medication
16. Subject is pregnant or planning to become pregnant
17. Subject is on worker's compensation
18. Subject has a concomitant procedure not including meniscectomy, synovectomy, chondroplasty, or removal of loose body
19. Inability to complete study requirements and follow-up visits
20. Subject that has a bone marrow aspiration that does not meet 60cc
18 Years
60 Years
ALL
No
Sponsors
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Arthrex, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Anz
Role: PRINCIPAL_INVESTIGATOR
Andrews Research and Education Foundation
Locations
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University of Colorado Sports Medicine
Denver, Colorado, United States
Andrews Research and Education Foundation
Gulf Breeze, Florida, United States
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, United States
The Ohio State University
Columbus, Ohio, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Alicia Ruiz, MS
Role: CONTACT
Facility Contacts
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Rachel Frank
Role: primary
Adam Anz
Role: primary
Jason Scopp
Role: primary
David Flanigan
Role: primary
Brian Mosier
Role: primary
Other Identifiers
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20085
Identifier Type: -
Identifier Source: org_study_id
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