NCT05314608 · Arthrex, Inc.
Knee Related Subchondral Bone Lesions Treated With IOBP
(IOBP)
What this study is about
The study will be a forward-looking, conducted at multiple hospitals 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).
View original scientific description
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).
Interventions
COMBINATION_PRODUCT
IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion
Primary outcome measures
Prevention of additional surgery into the target knee
Time frame: 5 years
To evaluate if IOBP® procedure will 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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®
Exclusion criteria
- 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
- Denver, Colorado
- Gulf Breeze, Florida
- Salisbury, Maryland
- Columbus, Ohio
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2022 · Source of record for eligibility and locations