Knee Related Subchondral Bone Lesions Treated With IOBP
ConditionSubchondral Cyst
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorArthrex, Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov