Early Regenerative Intervention for Post-Traumatic Osteoarthritis

Status unconfirmed · Not applicable

Conditions studied: Post-Traumatic Osteoarthritis of Knee

In brief

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.

Key facts

Study ID

NCT04222140

Run by

Affinity Health Research Institute

People needed

40

Starts

2020-08-01

Expected to finish

2021-09-01

Last updated by the study team

2020-01-09

Who can join

Age: 25 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• The Center for Primary Care and Sports Medicine — Aurora, Illinois, United States
• Affinity Health Research Institute — Oak Brook, Illinois, United States
• Genesis Orthopedics and Sports Medicine — Oak Brook, Illinois, United States

Full record on ClinicalTrials.gov

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