Knee Related Subchondral Bone Lesions Treated With IOBP

Recruiting now

Conditions studied: Subchondral Cyst

In brief

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 facts

Study ID: NCT05314608
Run by: Arthrex, Inc.
People needed: 100
Starts: 2021-11-17
Expected to finish: 2027-05-17
Last updated by the study team: 2022-12-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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®

You may not qualify if…

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

Where it is running

University of Colorado Sports Medicine — Denver, Colorado, United States (enrolling)
Andrews Research and Education Foundation — Gulf Breeze, Florida, United States (enrolling)
TidalHealth Peninsula Regional, Inc. — Salisbury, Maryland, United States (enrolling)
The Ohio State University — Columbus, Ohio, United States (enrolling)
Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.