Knee Related Subchondral Bone Lesions Treated With IOBP

Study Overview
=================
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).

Detailed Description
-----------------
The study will be a prospective, multicenter, clinical study, enrolling both male and female patients. Subjects will be identified among the investigators' patient population scheduled for the IOBP® procedure and as being diagnosed with symptomatic SBP that have failed conservative management. IRB approval will be obtained by each participating institution. The primary outcome measure is adverse event evaluation to determine whether IOBP® can 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.

Official Title
-----------------
Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique

Conditions
-----------------
Subchondral Cyst

Intervention / Treatment
-----------------
* Combination Product: IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with subchondral bone pathology<br>Subjects with subchondral bone pathology | Combination Product: IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee<br>* Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of additional surgery into the target knee | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale (VAS) | Patient reported pain scale using a 10 cm scale with a numeric rating of 0 to 10, with 0 | Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op. | 
| International Knee Documentation Committee Subjective Knee Evaluation Form | A patient-oriented questionnaire that assesses symptoms and function in daily living activities. The purpose of this study was to validate the IKDC Subjective Knee Form in a large patient population with various knee disorders. | knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | A knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. | Collected at pre-op, 1 week post-op, 6 weeks post-op, 3 months post-op, 6 months post-op , 1 years post-op , 2 years post-op, 3 years post-op , 4 years post-op and 5 years post-op | 
| X-rays of the knee | Images include weight-bearing AP, 45 degree weight bearing PA, lateral and merchant views. Images taken to determine location and status of subchondral bone lesion. | 6 months and 1 year | 
| MRI of the knee | Minimum 1.5 Tesla MRI (including coronal, axial, sagittal, lateral femur, and lateral tibial views). Image taken to determine location and status of subchondral bone lesion. | 6 months and 1 year |