Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subchondral Cyst
- Sponsor
- Arthrex, Inc.
- Enrollment
- 100
- Locations
- 5
- Primary Endpoint
- Prevention of additional surgery into the target knee
- Status
- Recruiting
- Last Updated
- 3 years ago
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.
Investigators
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- MRI of the knee(6 months and 1 year)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(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(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.)
- Visual Analog Pain Scale (VAS)(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(6 months and 1 year)