Clinical Trial Finder

Steroid Injection vs. BioDRestore for Patients With Knee OA

Study Purpose

This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female, aged 18 to 80 years.
  • - Willing and able to give voluntary informed consent to participate in this investigation.
  • - Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA diagnosed and confirmed by treating physician using standing x-ray).
  • - Candidate for intra-articular knee injection.
  • - BMI < 40

    Exclusion Criteria:

    - Patients who have received intra-articular injection(s) in the last 3 months.
  • - Patients who have undergone arthroscopic surgery on the study knee in the past year.
  • - Patients who have undergone arthroplasty on the study knee.
  • - Ligament instability - Diabetes (Type 1 or II) - Inflammatory arthropathies.
  • - Fibromyalgia or chronic fatigue syndrome.
  • - Female patient who is pregnant or nursing.
  • - Chronic use of narcotics.
  • - Any other reason (in the judgment of the investigator).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02767492
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 The Hawkins Foundation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Paul Siffri, MD
Principal Investigator Affiliation Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Knee Osteoarthritis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Steadman Hawkins Clinic of the Carolinas, Greenville, South Carolina

Status

Recruiting

Address

Steadman Hawkins Clinic of the Carolinas

Greenville, South Carolina, 29615

Site Contact

Kyle Adams, BS

[email protected]

864-454-7458

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