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Controlled Study of Autologous Protein Solution for Knee Osteoarthritis

A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the
efficacy of a single dose of Autologous Protein Solution (APS) in patients with
Osteoarthritis (OA) of the knee.

To see if you qualify for this clinical trial, visit zimmerbiomet.com/nstridetrial, text KNEE to 87888 or call 773-313-3077.

Eligibility Criteria

Inclusion Criteria:

- Male or female ≥ 21 and ≤ 80 years old at the time of screening

- Willingness and ability to comply with the study procedures and visit schedules and
ability to follow oral and written instructions

- A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 and an
absence of severe osteoarthritis

- Body Mass Index ≤ 40

- A qualifying WOMAC LK 3.1 pain subscale total score

- Has undergone at least one prior conservative osteoarthritis treatment

- Signed an institutional review board approved informed consent

Exclusion Criteria:

- Presence of clinically observed active infection in the index knee

- Presence of symptomatic osteoarthritis in the non-study knee

- Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout,
ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV,
viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis

- Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or
planned chemotherapeutic treatment

- Untreated symptomatic injury of the index knee

- Presence of surgical hardware or other foreign body intended to treat arthritis or
cartilage-related pathology in the index knee

- Previous cartilage repair procedure on the injured cartilage surface of the index
knee

- Arthroplasty or open surgery of the index knee within 6 months of screening

- Intra-articular steroid injection in the index knee within 3 months of screening

- Intra-articular hyaluronic acid injection in the index knee within 6 months of
screening

- Other intra-articular therapy in the index knee within 6 months prior to screening

- Orally administered systemic steroid use within 2 weeks of screening

- Planned/anticipated surgery of the index knee during the study period

- Skin breakdown at the knee where the injection is planned to take place

- Pregnant or nursing mothers or women planning on getting pregnant during the time
they will be participating in the study

- Participated in any investigational drug or device trial within 30 days prior to
screening

- Participated in any investigational biologic trial within 60 days prior to screening

Principal Investigator

Neil Segal, MD

Study Contact

Jason-Flor Sisante 913-574-0961, jsisante@kumc.edu

Estimated Completion Date

Monday, April 1, 2019

ClinicalTrials.gov #

NCT02905240
03/28/2017