Back to resultsSaline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis (PROGRESS IV)
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nSTRIDE APS
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Autologous Protein Solution, APS, intra-articular injection, osteoarthritis
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
Sites / Locations
- University of Alabama
- AVANT Research Associates, LLC
- Tucson Orthopaedic Institute, PC
- CORE Orthopaedic Medical Center
- University of California at Los Angeles
- University of California, San Francisco
- Andrews Research and Education Foundation (AREF)
- Florida Hospital Orthopaedic Institute and Fracture Care Center
- Comprehensive Clinical Trials, LLC
- Orthoillinois, Ltd.
- Orthopedic & Sports Medicine Center
- OrthoIndy
- Kansas University Medical Center Research Institute, Inc.
- Brigham and Women's Mass General Health Care Center
- Northwell Health - Great Neck
- Northwell Health - Lenox Hill
- Duke University Medical Center
- Wake Forest School of Medicine
- University of Cincinnati College of Medicine
- Ohio State University
- Joint Implant Surgeons, Inc
- University of Pittsburgh Medical Center
- The Campbell Foundation
- Baylor College of Medicine
- Texas Center for Joint Replacement
- University of Virginia
- OrthoVirginia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
nSTRIDE APS
Saline
Arm Description
Autologous Protein Solution prepared using the nSTRIDE APS Kit
Saline control
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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).
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).
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).
Adverse Events
Subjects experiencing at least one AE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02905240
Brief Title
Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Autologous Protein Solution, APS, intra-articular injection, osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nSTRIDE APS
Arm Type
Experimental
Arm Description
Autologous Protein Solution prepared using the nSTRIDE APS Kit
Arm Title
Saline
Arm Type
Other
Arm Description
Saline control
Intervention Type
Device
Intervention Name(s)
nSTRIDE APS
Other Intervention Name(s)
Autologous Protein Solution
Intervention Description
single intra-articular injection
Intervention Type
Device
Intervention Name(s)
Saline
Intervention Description
single intra-articular injection
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months
Description
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).
Time Frame
Baseline and 12 Months
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months
Description
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.
Time Frame
Baseline and 12 Months
Title
Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders
Description
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).
Time Frame
12 months
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months
Description
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).
Time Frame
Baseline and 12 Months
Title
EQ-5D Change From Baseline to 12 Months
Description
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).
Time Frame
Baseline and 12 Months
Title
Adverse Events
Description
Subjects experiencing at least one AE
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick M Azar, M.D.
Organizational Affiliation
Campbell Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
AVANT Research Associates, LLC
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
Tucson Orthopaedic Institute, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
CORE Orthopaedic Medical Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Andrews Research and Education Foundation (AREF)
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Florida Hospital Orthopaedic Institute and Fracture Care Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Comprehensive Clinical Trials, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Orthoillinois, Ltd.
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Facility Name
Orthopedic & Sports Medicine Center
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
OrthoIndy
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Kansas University Medical Center Research Institute, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Brigham and Women's Mass General Health Care Center
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Facility Name
Northwell Health - Great Neck
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Northwell Health - Lenox Hill
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Joint Implant Surgeons, Inc
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
The Campbell Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Center for Joint Replacement
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
OrthoVirginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26915009
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.
Results Reference
background
PubMed Identifier
27668131
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.
Results Reference
background
Learn more about this trial
Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis
We'll reach out to this number within 24 hrs