Clinical trial NCT02768155: Evaluation of Amniotic Fluid Product in Knee Osteoarthritis
Official title: Protocol for the Clinical Evaluation Amniotic Fluid (AF) Product in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: OA, Osteoarthritis, Knee
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of subjects with osteoarthritic (OA) knee pain


Eligibility criteria: Inclusion Criteria:

1. Subject is 30 years or older.
2. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
3. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.

Exclusion Criteria:

1. Subject has active infection at the injection site.
2. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
3. BMI greater than 45 kg/m2
4. Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
5. Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 3 months prior to screening.
6. Subject has had major surgery, arthroplasty or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
7. Subject is pregnant or plans to become pregnant within 180 days of treatment.
8. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
9. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
11. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
12. Subject has had prior radiation at the site
13. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
14. Diagnosis of gout in the past 6 month
15. Subject has a diagnosis of osteoarthritis

Primary outcomes:
measure: Reduction in Pain
timeFrame: 3 months
Secondary outcomes:
measure: Range of Motion
timeFrame: 3 month
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 3 month
measure: WOMAC
timeFrame: 3 month
measure: Kellgren-Lawrence grade of OA
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc
state: Alabama
city: Des Plaines
country: United States
facility: Weil Foot, Ankle and Orthopedic Institute
state: Illinois
Study officials:
affiliation: MiMedx Group, Inc.
name: Donald Fetterolf, MD
role: STUDY_DIRECTOR
References: