Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis (PROGRESS IV)

Zimmer Biomet

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: Saline; Device: nSTRIDE APS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02905240

APSS-44-00

Details and patient eligibility

About

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.

Full description

A double-blind, multicenter, randomized, saline-controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with prior treatment.

Enrollment: 332 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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332 participants in 2 patient groups

nSTRIDE APS

Experimental group

Description:

Autologous Protein Solution prepared using the nSTRIDE APS Kit

Treatment:

Device: nSTRIDE APS

Saline

Other group

Description:

Saline control

Treatment:

Device: Saline