Recruiting

IOBP

Sponsor:

Arthrex, Inc.

Code:

NCT05314608

Conditions

Subchondral Cyst

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee

Study Details

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 system to treat subchondral bone pathology (SBP).

Conditions

Subchondral Cyst

Study ID

NCT05314608

Start date

Nov 17, 2021

Status verified date

Dec, 2022

Completion date

May 17, 2027

Anticipated

Primary completion date

May 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Able to read, understand, sign and complete informed consent
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:

1. Subject has diabetes Type I, Type II uncontrolled, or Type II insulin dependent
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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects with subchondral bone pathology

Subjects with subchondral bone pathology

Interventions

IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee

Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion

Primary outcome measure

  • Prevention of additional surgery into the target knee [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado Sports Medicine

Recruiting

Denver, Colorado, United States, 80222

Principal Investigator:

Rachel Frank

Andrews Research and Education Foundation

Recruiting

Gulf Breeze, Florida, United States, 32561

Contacts

Principal Investigator:

Adam Anz

TidalHealth Peninsula Regional, Inc.

Recruiting

Salisbury, Maryland, United States, 21801

Principal Investigator:

Jason Scopp

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43201

Principal Investigator:

David Flanigan

Allegheny-Singer Research Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Principal Investigator:

Brian Mosier

More Information

Sponsor

Arthrex, Inc.

Last update posted

Dec 5, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arthrex, Inc. on 2022-12-05.