Early Regenerative Intervention for Post-Traumatic Osteoarthritis

NCT04222140 | Unknown FDA Device

• 1 other identifier: ERIPTO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of the proposed research is to compare the ERIPTO protocol for post-traumatic osteoarthritis of the knee with that of bone marrow aspirate concentrate (BMAC) only. The investigators will also conduct a statistical regression analysis looking into factors such as time frame from initial injury, the type of injury, gender, and age when injury first occurred. The investigators plan on evaluating clinically and radiographically the effects of the ERIPTO Protocol. There will be two arms of this study. The first arm will be our protocol arm and the second arm will be our BMAC treatment only arm. The investigators plan on collecting objective data on osteoarthritis (OA) severity by taking plain films and assessing the Kellgren-Lawrence (KL) grading scheme in assessing OA severity. The investigators will also administer MRI evaluations for cartilage and meniscal growth prior to treatment and after 1 year. The investigators also plan on collecting subjective symptom scores in the form of knee injury and osteoarthritis outcomes scores (KOOS), visual analog scores (VAS), and international knee documentation criteria (IKDC) score for OA severity. The investigators plan to track changes in both subjective and objective measures of knee OA in our patients through the course of one year.

Conditions

Post-Traumatic Osteoarthritis of Knee

Keywords

sports medicine; regenerative medicine; bone marrow derived mesenchymal stem cells; platelet rich plasma; hyaluronic acid; post-traumatic osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Radiographic Changes

  Magnetic resonance imaging evaluations pre-treatment and post-treatment measuring evidence of changes in post-traumatic osteoarthritis of the knee including articular cartilage quality, presence of subchondral bone marrow edema, presence of osteophytes, medial and lateral meniscal quality, ligamentous integrity, and presence of effusion.

  1 year

• Radiographic Changes

  Kellgren Lawrence grading system will be utilized analyzing pre-treatment and post-treatment radiographs of the knee. Grading is from I-IV with I being minimal to mild disease and IV being end stage joint disease.

  1 year

Secondary Outcomes (3)

• Subjective Knee Symptom Changes

  1 year

• Subjective Knee Symptom Changes

  1 year

• Subjective Knee Symptom Changes

  1 year

Study Arms (2)

ERIPTO Protocol

EXPERIMENTAL

Protocol arm actively being studied

Combination Product: ERIPTO Protocol

BMAC only

ACTIVE COMPARATOR

bone marrow aspirate concentrate only arm

Biological: BMAC Only

Interventions

ERIPTO Protocol COMBINATION_PRODUCT

combination biologic treatment

ERIPTO Protocol

BMAC Only BIOLOGICAL

BMAC treatment only

BMAC only

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 25-60 men and women
• evidence of OA both clinically and on plain films, at least KL grade 1
• no previous intra-articular treatment in the past 3 months
• In good health and active individuals exercising 1-2 times per week
• BMI 25-30
• History of meniscal, ligamentous, capsular, or articular cartilage lesions in the past
• History of impaction injury, femoral condyle fracture, tibial plateau fracture, or any OCD lesions within ≤ 5 years

You may not qualify if:

• Patients receiving regenerative therapies within the last 12 months
• Patients receiving corticosteroid injections within the last 3 months
• Patients with artificial joints
• Patients with secondary OA from non-traumatic mechanisms (i.e. RA or any inflammatory arthropathies)
• Patients with multiple co-morbidities that may affect the inflammatory state
• History of sleep disorders
• History of residual irregularity of articular surfaces, excessive joint instability
• History of impaction injury, femoral condyle fracture, tibial plateau fracture, or OCD lesions \> 5 years
• History of malignancy, blood dyscrasias, or platelet dysfunction
• Active systemic or local infections, particularly with Klebsiella Pneumoniae, Enterococcus, and Pseudomonas

Sponsors & Collaborators

• Affinity Health Research Institute: lead
• Genesis Orthopedics and Sports Medicine: collaborator
• The Center for Primary Care and Sports Medicine: collaborator

Study Sites (3)

The Center for Primary Care and Sports Medicine

Aurora, Illinois, 60504, United States

Location

Affinity Health Research Institute

Oak Brook, Illinois, 60523, United States

Location

Genesis Orthopedics and Sports Medicine

Oak Brook, Illinois, 60523, United States

Location

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Study Officials

• Mohammed M Qureshi, DO, CAQSM, MRO

  Affinity Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Director of Research and Operations

CONTACT

630-491-1908; Sheela@affinityhealthcorp.com

Mohammed M Qureshi, DO, CAQSM, MRO

CONTACT

281-702-7586; mqureshi@affinityhealthcorp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 9, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)