Knee Related Subchondral Bone Lesions Treated With IOBP
Part of paid clinical trials in Denver, Colorado.
- Sponsor
- Arthrex, Inc.
- Study ID
- NCT05314608
- Status
- Recruiting
Conditions
- Subchondral Cyst
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee — COMBINATION_PRODUCTInjection of a biologic mixture (BMC and allograft) into the subchondral bone lesion
Study Details
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).
Key Dates
- Start date
- Nov 17, 2021
- Status verified
- Dec 2022
- Primary completion
- May 17, 2027
- Completion
- May 17, 2027
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: Subjects with subchondral bone pathologySubjects with subchondral bone pathology
Primary Outcome Measure
Prevention of additional surgery into the target knee [ Time Frame: 5 years ]
Central Contacts
- Justin W Moss, DHSc770 584 4972
- Alicia Ruiz, MS1 (800) 933-7001
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado Sports Medicine | Denver | Colorado | 80222 | Rachel Frank Rachel Frank (PRINCIPAL_INVESTIGATOR) |
| Andrews Research and Education Foundation | Gulf Breeze | Florida | 32561 | Adam Anz 850-916-8575 Adam Anz (PRINCIPAL_INVESTIGATOR) |
| TidalHealth Peninsula Regional, Inc. | Salisbury | Maryland | 21801 | Jason Scopp Jason Scopp (PRINCIPAL_INVESTIGATOR) |
| The Ohio State University | Columbus | Ohio | 43201 | David Flanigan David Flanigan (PRINCIPAL_INVESTIGATOR) |
| Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | Brian Mosier Brian Mosier (PRINCIPAL_INVESTIGATOR) |