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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
Combination productInjection of a biologic mixture (BMC and allograft) into the subchondral bone lesion
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Subjects with subchondral bone pathology1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
5 yearsSecondary outcomes
1
Visual Analog Pain Scale (VAS)
Patient reported pain scale using a 10 cm scale with a numeric rating of 0 to 10, with 0
Time frame
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.2
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.
Time frame
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.3
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.
Time frame
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-op4
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.
Time frame
6 months and 1 yearSponsors and contacts
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Source ClinicalTrials.gov