Evaluate Efficacy of US-guided PRP and MFAT Injections for Patients with Abnormal SI Ligamentous Laxity

Principal Investigator:

Dr. Timothy Mazzola

MD, Penn State University College of Medicine

Triple board-certified in family medicine, sports medicine, and musculoskeletal ultrasound. Practices as a non-operative orthopedic and regenerative medicine specialist at Breakthrough Regenerative Orthopedics in Boulder, Colorado. Assistant clinical professor at the University of Colorado. National expert and highly sought-after physician educator who has taught musculoskeletal and sports ultrasound at the Gulfcoast Ultrasound Institute and Advanced US courses at the American Medical Society of Sports Medicine National Conferences.

Study Abstract:

Instability of the sacroiliac (SI) ligament and its myofascial attachments can induce pain and dysfunction in the lower back, hip and knee regions. Treatment of the secondary symptomatic areas, as opposed to the SI ligament and myofascial attachments, fails to address the primary root cause of pain and dysfunction in these regions.

This Circle uses a unique physical examination objective measurement, “Millimeters of Motion,” to quantify SI ligamentous laxity prior to and following orthobiologics treatments, including platelet-rich plasma (PRP) and micro-fragmented adipose tissue (MFAT) injections. The study further captures validated patient-reported outcomes of lower back, hip and overall pain levels over a 12-month period.

Study Type:

Observational, Quality Improvement

Circle Benefits:
  • Access to education on how to assess for SI ligamentous laxity.
  • Access to a retrospective database demonstrating reduction of laxity and patient symptoms following orthobiologics treatment options.
  • Turnkey solution for engaging your own everyday patients in self-reported outcomes tracking.
  • Benchmarking of results and methods against all other Circle contributors.
  • Access to innovative biological products involved within the study.
Real-World Data Surveys:
  • Visual Analogue Scale (VAS)
  • Revised Oswestry Disability Index (ODI)
  • Hip Dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
Circle Type:

Private Circle

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Additional Resources:

Evaluate Efficacy of US-guided PRP and MFAT Injections for Patients with Abnormal SI Ligamentous Laxity

Circle Objective Abstract:

Instability of the sacroiliac (SI) ligament and its myofascial attachments can induce pain and dysfunction in the lower back, hip and knee regions. Treatment of the secondary symptomatic areas, as opposed to the SI ligament and myofascial attachments, fails to address the primary root cause of pain and dysfunction in these regions.

This Circle uses a unique physical examination objective measurement, “Millimeters of Motion,” to quantify SI ligamentous laxity prior to and following orthobiologics treatments, including platelet-rich plasma (PRP) and micro-fragmented adipose tissue (MFAT) injections. The study further captures validated patient-reported outcomes of lower back, hip and overall pain levels over a 12-month period.

Real-World Data Surveys:

VAS; ODI; HOOS, Jr

Intervention:

Circle Benefits:
  • Access to education on how to assess for SI ligamentous laxity.
  • Access to a retrospective database demonstrating reduction of laxity and patient symptoms following orthobiologics treatment options.
  • Turnkey solution for engaging your own everyday patients in self-reported outcomes tracking.
  • Benchmarking of results and methods against all other Circle contributors.
  • Access to innovative biological products involved within the study.

Streamlined patient enrollment, real-world data capturing, heightened recognition, prominence and collaboration

Circle Type:

Private Circle

Supporting Materials
Interested in learning more about this Circle?

CIRCLE LIBRARY

CIRCLE NAME

Total Knee Arthroplasty Outcome-Based Performance Measure

SURVEYS

OUTCOMES SURVEYS

VAS
KOOS Jr.
VR-12 (compliant with CMS/IQR Requirements)

CLINICAL SURVEYS

As specified by Provider

THIS CIRCLE IS FOR:

Provider Receiving CMS Reimbursement For TKAs

CMS will soon penalize providers performing total knee replacements which do not collect specified outcomes data from at least 50% of qualifying patients.

Other Providers Performing TKAs

Private insurance companies and other payers within and outside the U.S. will follow the CMS lead in requiring high patient compliance in reporting long-term TKA outcomes.

WHY CIRCLES

Clinical Grade
Excellent
Surgeon User
Experience
Excellent
Patient
Experience
Provider
Ownership
and Control
A Profit Center
Patented technology
HIPAA, GDPR, GCP and Part 11 compliant
Multilingual
Scalable
Easily export to, integrate with, existing systems
Robust reporting functions
Illustrative Materials

Clinical Grade — Circles

Circles are applicable to any medical specialty, indication or patient population. Each Circle is focused on a specific clinical or scientific topic of interest to its Members.

Clinical Grade — Data Access

inCytes™ permissions settings give Circle Investigators full control over their individual data sets, while preserving the ability to share aggregated datasets.

Clinical Grade — Observational Protocols

Observational Protocols are fully configurable for various use cases and organized within Circles for easy access and sharing among investigators, ensuring that all data shared is standardized and clinically useful.

Clinical Grade — Surveys / PROMs

Surveys comprise custom-designed queries related to a specific topic, such as outcomes, clinical methodologies, lab testing, and more, incorporating the logic to help ensure accurate, efficient, and if needed, longitudinal capture.

Clinical Grade — Report Builder #1

Comparing KOOS, JR. results over 12 months among three separate patient cohorts: (i) All Patients age 65 – 75, n=31 (ii) All Patients age 75 or older, n=127 and (iii) All Patients with a BMI over 30, n=93.

Clinical Grade — Report Builder #2

Comparing VAS results over 12 months among three separate patient cohorts: (i) All Female Patients treated at a specific hospital, n=60 (ii) All Male Patients treated at the same hospital, n=70 and (iii) All Patients, n=207.

Clinical Grade — Report Builder #3

Comparing KOOS, JR. results over 12 months among four separate patient cohorts: (i) All Patients for a specific surgeon (Evans), n=15 (ii) All Patients for that surgeon’s hospital, n=48, (iii) All Patients, n=207, and (iv) All Patients for another specific surgeon at the same hospital (Vogt), n=16.
Left arrow in circle
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Minimal administrative and clinical burden
Accommodates surgical variations
All data accessible 24/7 from any device
Allows extensive customization
Inherent collaboration among peers
Improves clinical decision-making
Adjustable outcomes alerts
Regular reports on key metrics
Automatic patient consent capture
Illustrative Materials

Excellent Surgeon User Experience — Surveys

Circles enhance the user experience for busy practitioners by minimizing administrative tasks, streamlining data entry, and automating processes, thereby reducing paperwork and improving client interaction for quick access to information.

Excellent Surgeon User Experience — Patient Consent

Patient Consent can be customized as needed. We securely track and record the consent and its acceptance, ensuring that Company personnel do not access this information.

Excellent Surgeon User Experience — Investigators

inCytes™ facilitates seamless Circle participation for clinicians, including physician assistants and laboratory technicians, across institutional and national boundaries, while enabling the tracking and assessment of member performance and engagement.

Excellent Surgeon User Experience — Circle Analytics

RegenMed offers a suite of analytics that provides insights into patient engagement and research collaboration, including metrics on patient compliance, shared Cases among Circle investigators, and total data points captured.
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Sustained onboarding and follow-up processes
Communication of condition and protocol education materials *
Regular progress reports *
Cohort comparisons *
Newsletters, other patient communications *
*  Provider defined
Illustrative Materials

Excellent Patient Experience — Sustained onboarding and follow-up processes

Benchmarc™ provides an ongoing two-way channel between the patient and his/her doctor throughout the clinical journey.

Excellent Patient Experience — Patient Education Materials

Patients are provided with a comprehensive overview of their medical condition and available treatment options, which helps them better understand their health.  

Excellent Patient Experience — Regular Progress Reports

Patients can track their progress on the graph, noting milestones such as completed surveys and engagement. The user-friendly design allows all patients to easily interpret their data and stay motivated throughout treatment.
Left arrow in circle
Right arrow in circle
Clear ownership of validated anonymized datasets
Copyrightable
Right to publish
Right to monetize
Illustrative Materials

Excellent Patient Experience — Circle Analytics

Circles enhance the user experience for busy practitioners by minimizing administrative tasks, streamlining data entry, and automating processes, thereby reducing paperwork and improving client interaction for quick access to information.
Left arrow in circle
Right arrow in circle
Not a point solution, but a strategic initiative
Easily extensible and scalable
Accommodates Health Equity initiatives
Accommodates CMS Hospital Value Program and other Value-Based Care initiatives
Clinical Grade
Patented technology
HIPAA, GDPR, GCP and Part 11 compliant
Multilingual
Scalable
Robust reporting functions
Easily export to, integrate with, existing systems
Illustrative Materials

Clinical Grade — Circles

Circles are applicable to any medical specialty, indication or patient population. Each Circle is focused on a specific clinical or scientific topic of interest to its Members.

Clinical Grade — Data Access

inCytes™ permissions settings give Circle Investigators full control over their individual data sets, while preserving the ability to share aggregated datasets.

Clinical Grade — Observational Protocols

Observational Protocols are fully configurable for various use cases and organized within Circles for easy access and sharing among investigators, ensuring that all data shared is standardized and clinically useful.

Clinical Grade — Surveys / PROMs

Surveys comprise custom-designed queries related to a specific topic, such as outcomes, clinical methodologies, lab testing, and more, incorporating the logic to help ensure accurate, efficient, and if needed, longitudinal capture.

Clinical Grade — Report Builder #1

Comparing KOOS, JR. results over 12 months among three separate patient cohorts: (i) All Patients age 65 – 75, n=31 (ii) All Patients age 75 or older, n=127 and (iii) All Patients with a BMI over 30, n=93.

Clinical Grade — Report Builder #2

Comparing VAS results over 12 months among three separate patient cohorts: (i) All Female Patients treated at a specific hospital, n=60 (ii) All Male Patients treated at the same hospital, n=70 and (iii) All Patients, n=207.

Clinical Grade — Report Builder #3

Comparing KOOS, JR. results over 12 months among four separate patient cohorts: (i) All Patients for a specific surgeon (Evans), n=15 (ii) All Patients for that surgeon’s hospital, n=48, (iii) All Patients, n=207, and (iv) All Patients for another specific surgeon at the same hospital (Vogt), n=16.
Left arrow in circle
Right arrow in circle
Excellent
Surgeon User
Experience
Minimal administrativeand clinical burden
Accommodates surgical variations
All data accessible 24/7 from any device
Allows extensive customization
Inherent collaboration among peers
Improves clinical decision-making
Adjustable outcomes alerts
Regular reports on key metrics
Automatic patient consent capture
Illustrative Materials

Excellent Surgeon User Experience — Surveys

Circles enhance the user experience for busy practitioners by minimizing administrative tasks, streamlining data entry, and automating processes, thereby reducing paperwork and improving client interaction for quick access to information.

Excellent Surgeon User Experience — Patient Consent

Patient Consent can be customized as needed. We securely track and record the consent and its acceptance, ensuring that Company personnel do not access this information.

Excellent Surgeon User Experience — Investigators

inCytes™ facilitates seamless Circle participation for clinicians, including physician assistants and laboratory technicians, across institutional and national boundaries, while enabling the tracking and assessment of member performance and engagement.

Excellent Surgeon User Experience — Circle Analytics

RegenMed offers a suite of analytics that provides insights into patient engagement and research collaboration, including metrics on patient compliance, shared Cases among Circle investigators, and total data points captured.
Left arrow in circle
Right arrow in circle
Excellent
Patient
Experience
Sustained onboarding and follow-up processes
Communication of condition and protocol education materials *
Regular progress reports *
Cohort comparisons *
Newsletters, other patient communications *
*  Provider defined
Illustrative Materials

Excellent Patient Experience — Sustained onboarding and follow-up processes

Benchmarc™ provides an ongoing two-way channel between the patient and his/her doctor throughout the clinical journey.

Excellent Patient Experience — Patient Education Materials

Patients are provided with a comprehensive overview of their medical condition and available treatment options, which helps them better understand their health.  

Excellent Patient Experience — Regular Progress Reports

Patients can track their progress on the graph, noting milestones such as completed surveys and engagement. The user-friendly design allows all patients to easily interpret their data and stay motivated throughout treatment.
Left arrow in circle
Right arrow in circle
Provider
Ownership
and Control
Clear ownership of validated anonymized datasets
Copyrightable
Right to publish
Right to monetize
A Profit Center
Not a point solution, but a strategic initiative
Easily extensible and scalable
Accommodates Health Equity initiatives
Accommodates CMS Hospital Value Program and other Value-Based Care initiatives
Interested in this Circle?

If you have any questions, please contact us.

APPLY TO JOIN

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