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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with subchondral bone pathology | Subjects with subchondral bone pathology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee | Combination Product | Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin W Moss, DHSc | Contact | 770 584 4972 | justin.moss@arthrex.com | |
| Alicia Ruiz, MS | Contact | 1 (800) 933-7001 | 71970 |
| Name | Affiliation | Role |
|---|---|---|
| Adam Anz | Andrews Research and Education Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Sports Medicine | Recruiting | Denver | Colorado | 80222 | United States |
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| ID | Term |
|---|---|
| D001845 | Bone Cysts |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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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 |
| Andrews Research and Education Foundation | Recruiting | Gulf Breeze | Florida | 32561 | United States |
|
| TidalHealth Peninsula Regional, Inc. | Recruiting | Salisbury | Maryland | 21801 | United States |
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| The Ohio State University | Recruiting | Columbus | Ohio | 43201 | United States |
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| Allegheny-Singer Research Institute | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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