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Early Regenerative Intervention for Post-Traumatic Osteoarthritis

NCT04222140 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-09

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

ERIPTO Protocol

combination biologic treatment

BIOLOGICAL

BMAC Only

BMAC treatment only

Sponsors & Collaborators

  • Genesis Orthopedics and Sports Medicine

    collaborator UNKNOWN

  • The Center for Primary Care and Sports Medicine

    collaborator UNKNOWN

  • Affinity Health Research Institute

    lead OTHER

Principal Investigators

  • Mohammed M Qureshi, DO, CAQSM, MRO · Affinity Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-08-01
Completion
2021-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04222140 on ClinicalTrials.gov