Clinical trial NCT02905240: Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis
Official title: A Multicenter, Double-Blind, Randomized, Saline-Controlled Study of a Single, Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Autologous Protein Solution
APS
intra-articular injection
osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2016-09-19
Enrollment: 332
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months
timeFrame: Baseline and 12 Months
Secondary outcomes:
measure: Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months
timeFrame: Baseline and 12 Months
measure: Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders
timeFrame: 12 months
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months
timeFrame: Baseline and 12 Months
measure: EQ-5D Change From Baseline to 12 Months
timeFrame: Baseline and 12 Months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Guntersville
country: United States
facility: AVANT Research Associates, LLC
state: Alabama
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute, PC
state: Arizona
city: Encinitas
country: United States
facility: CORE Orthopaedic Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Gulf Breeze
country: United States
facility: Andrews Research and Education Foundation (AREF)
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orthopaedic Institute and Fracture Care Center
state: Florida
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials, LLC
state: Florida
city: Rockford
country: United States
facility: Orthoillinois, Ltd.
state: Illinois
city: Elkhart
country: United States
facility: Orthopedic & Sports Medicine Center
state: Indiana
city: Greenwood
country: United States
facility: OrthoIndy
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center Research Institute, Inc.
state: Kansas
city: Foxboro
country: United States
facility: Brigham and Women's Mass General Health Care Center
state: Massachusetts
city: Great Neck
country: United States
facility: Northwell Health - Great Neck
state: New York
city: New York
country: United States
facility: Northwell Health - Lenox Hill
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: New Albany
country: United States
facility: Joint Implant Surgeons, Inc
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Germantown
country: United States
facility: The Campbell Foundation
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Plano
country: United States
facility: Texas Center for Joint Replacement
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: OrthoVirginia
state: Virginia
Study officials:
affiliation: Campbell Clinic
name: Frederick M Azar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: King W, van der Weegen W, Van Drumpt R, Soons H, Toler K, Woodell-May J. White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution. J Exp Orthop. 2016 Dec;3(1):9. doi: 10.1186/s40634-016-0043-7. Epub 2016 Feb 9.
citation: van Drumpt RA, van der Weegen W, King W, Toler K, Macenski MM. Safety and Treatment Effectiveness of a Single Autologous Protein Solution Injection in Patients with Knee Osteoarthritis. Biores Open Access. 2016 Aug 1;5(1):261-8. doi: 10.1089/biores.2016.0014. eCollection 2016.