Subchondral CystIOBPNCT05314608
Knee Related Subchondral Bone Lesions Treated With IOBP
An observational study of Subchondral Cyst, run by Arthrex, Inc. at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Subchondral Cyst
- What is being tested?
- IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Nov 2021to 17 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study 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.
Who may be able to join
- 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®
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alicia Ruiz, MS contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43201
David Flanigan
David Flanigan
- Recruiting
University of Colorado Sports Medicine
Denver, Colorado, 80222
Rachel Frank
Rachel Frank
- Recruiting
Andrews Research and Education Foundation
Gulf Breeze, Florida, 32561
Adam Anz, 850-916-8575
Adam Anz
- Recruiting
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
Brian Mosier
Brian Mosier
- Recruiting
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21801
Jason Scopp
Jason Scopp
About this study
Official title: Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique
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).
Read the 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.
- Conditions
- Subchondral Cyst
- Being tested
- IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee
- Medical subject headings
- Bone Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the kneeCombination product
Injection of a biologic mixture (BMC and allograft) into the subchondral bone lesion
| Study group | Role | What they receive |
|---|---|---|
| Subjects with subchondral bone pathology | Subjects with subchondral bone pathology Receives: Combination Product: IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (5)
Visual Analog Pain Scale (VAS)
Patient reported pain scale using a 10 cm scale with a numeric rating of 0 to 10, with 0
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start17 Nov 2021
- Primary completion17 May 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subchondral CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Anz, Principal investigator, Andrews Research and Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314608
- Sponsor's protocol ID
- 20085
- Acronym
- IOBP
- Status last verified
- Dec 2022
- First submitted
- 23 Feb 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Bone Pathologies Resulting From Acute or Chronic Injury Treated With IntraOsseous BioPlasty® (IOBP®) Surgical Technique
- ClinicalTrials.gov ID
- NCT05314608
- Acronym / sponsor ID
- IOBP / 20085
- Conditions
- Subchondral Cyst
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with subchondral bone pathology | – | Combination Product: IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the kneeSubjects with subchondral bone pathology |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IntraOsseous BioPlasty® (IOBP®) Surgical Technique into the kneeInjection of a biologic mixture (BMC and allograft) into the subchondral bone lesion | Combination product | Subjects with subchondral bone pathology |
Primary outcome
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.
5 secondary outcomes
Visual Analog Pain Scale (VAS)
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
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)
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
Time frame: 6 months and 1 year
MRI of the knee
Time frame: 6 months and 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Subchondral Cyst
Recruiting
Marrow Cellution™ vs. Traditional BMA Harvest Project
Hip Arthropathy, Avascular Necrosis of Bone
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alicia Ruiz, MS contact
Adam Anz principal investigator
Andrews Research and Education Foundation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subchondral Cyst, run by Arthrex, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin W Moss, DHSc (770 584 4972, justin.moss@arthrex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of additional surgery into the target knee (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.