Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

Osteoarthritis Clinical Trial

— PROGRESS IV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905240
• Other study ID #: APSS-44-00
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: June 2020

Study information

• Verified date: October 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: June 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• nSTRIDE APS
single intra-articular injection
• Saline
single intra-articular injection

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of Virginia	Charlottesville	Virginia
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Orthopedic & Sports Medicine Center	Elkhart	Indiana
United States	CORE Orthopaedic Medical Center	Encinitas	California
United States	Brigham and Women's Mass General Health Care Center	Foxboro	Massachusetts
United States	The Campbell Foundation	Germantown	Tennessee
United States	Northwell Health - Great Neck	Great Neck	New York
United States	OrthoIndy	Greenwood	Indiana
United States	Andrews Research and Education Foundation (AREF)	Gulf Breeze	Florida
United States	AVANT Research Associates, LLC	Guntersville	Alabama
United States	Baylor College of Medicine	Houston	Texas
United States	Kansas University Medical Center Research Institute, Inc.	Kansas City	Kansas
United States	University of California at Los Angeles	Los Angeles	California
United States	Joint Implant Surgeons, Inc	New Albany	Ohio
United States	Northwell Health - Lenox Hill	New York	New York
United States	Florida Hospital Orthopaedic Institute and Fracture Care Center	Orlando	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Texas Center for Joint Replacement	Plano	Texas
United States	OrthoVirginia	Richmond	Virginia
United States	Orthoillinois, Ltd.	Rockford	Illinois
United States	University of California, San Francisco	San Francisco	California
United States	Tucson Orthopaedic Institute, PC	Tucson	Arizona
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months	The primary objective of this study was to determine whether nSTRIDE APS is superior to Saline with respect to the improvement in mean WOMAC Pain score (change from baseline to 12 Months post-injection raw score). The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain).	Baseline and 12 Months
Secondary	Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months	The Visual Analogue Scale is a common tool for measuring general pain. A 100 mm line is marked from 0 to 10 in 10 mm increments. Knee pain severity is indicated by drawing a vertical mark at the point on the line that best represents the severity of pain. No pain is indicated by the 0 at the far left, and the worst possible pain is indicated by the 100 at the far right.	Baseline and 12 Months
Secondary	Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders	The OMERACT-OARSI Responder Criteria were applied to both treatment groups, categorizing each patient into one of two categories: responder and non-responder. Responders were defined as subjects who achieved a high degree of improvement in pain or in function (improvement of =50% and absolute change =20), or a moderate degree of improvement in 2 of the 3 response domains (pain, function, global assessment).	12 months
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months	The WOMAC stiffness subscale consisted of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness).	Baseline and 12 Months
Secondary	EQ-5D Change From Baseline to 12 Months	The EQ-5D is a validated instrument that assesses an individual's current health status and heath related quality of life. The EQ-5D-3L descriptive component assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression over three levels of severity. The EQ visual analogue scale (EQ VAS) assesses the respondent's self-rated overall health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline and 12 Months
Secondary	Adverse Events	Subjects experiencing at least one AE	12 months