An observational study in Subchondral Cyst, sponsored by Arthrex, Inc.. Recruiting at 5 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by Arthrex, Inc. · Observational
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.
18 studies on the registry are indexed under Bone Cysts; 5 are open to participants now.
Browse Bone Cysts studies →Arthrex, Inc. is the lead sponsor of 18 studies on the registry; 7 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with subchondral bone pathology
Combination Product: IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion
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 years
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.
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.
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-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.
Time frame: 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.
Time frame: 6 months and 1 year
Plan to share: No
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Arthrex, Inc.