OsteoarthritisPROGRESS IVNCT02905240
Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis
A study testing nSTRIDE APS and Saline in people with Osteoarthritis, run by Zimmer Biomet at 27 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- nSTRIDE APS and Saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 27 sitesUnited States
- Study dates
- Nov 2016to Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
University of Alabama
Birmingham, Alabama, 35294
University of Virginia
Charlottesville, Virginia, 22903
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45229
Ohio State University
Columbus, Ohio, 43221
Duke University Medical Center
Durham, North Carolina, 27710
Orthopedic & Sports Medicine Center
Elkhart, Indiana, 46514
CORE Orthopaedic Medical Center
Encinitas, California, 92024
Brigham and Women's Mass General Health Care Center
Foxborough, Massachusetts, 02035
The Campbell Foundation
Germantown, Tennessee, 38138
Northwell Health - Great Neck
Great Neck, New York, 11021
OrthoIndy
Greenwood, Indiana, 46143
Andrews Research and Education Foundation (AREF)
Gulf Breeze, Florida, 32561
AVANT Research Associates, LLC
Guntersville, Alabama, 35976
Baylor College of Medicine
Houston, Texas, 77030
Kansas University Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
University of California at Los Angeles
Los Angeles, California, 90095
Joint Implant Surgeons, Inc
New Albany, Ohio, 43054
Northwell Health - Lenox Hill
New York, New York, 10065
Florida Hospital Orthopaedic Institute and Fracture Care Center
Orlando, Florida, 32804
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Texas Center for Joint Replacement
Plano, Texas, 75093
OrthoVirginia
Richmond, Virginia, 23294
Orthoillinois, Ltd.
Rockford, Illinois, 61114
University of California, San Francisco
San Francisco, California, 94158
Tucson Orthopaedic Institute, PC
Tucson, Arizona, 85712
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- nSTRIDE APS, Saline
- Keywords
- Autologous Protein Solution, APS, intra-articular injection, osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nSTRIDE APSDevice
Also called Autologous Protein Solution
single intra-articular injection
SalineDevice
single intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| nSTRIDE APS | Experimental | Autologous Protein Solution prepared using the nSTRIDE APS Kit Receives: Device: nSTRIDE APS |
| Saline | Other | Saline control Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 12 Months
Secondary outcomes (5)
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.
Measured: Baseline and 12 Months
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).
Measured: 12 months
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).
Measured: Baseline and 12 Months
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).
Measured: Baseline and 12 Months
Adverse Events
Subjects experiencing at least one AE
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick M Azar, M.D., Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905240
- Sponsor's protocol ID
- APSS-44-00
- Acronym
- PROGRESS IV
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2016
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26915009van 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.
PubMed 27668131
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02905240
- Acronym / sponsor ID
- PROGRESS IV / APSS-44-00
- Conditions
- Osteoarthritis
- Keywords
- Autologous Protein Solution, APS, intra-articular injection, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Posted 19 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nSTRIDE APS | Experimental | Device: nSTRIDE APSAutologous Protein Solution prepared using the nSTRIDE APS Kit |
| Saline | Other | Device: SalineSaline control |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nSTRIDE APSAlso: Autologous Protein Solutionsingle intra-articular injection | Device | nSTRIDE APS |
| Salinesingle intra-articular injection | Device | Saline |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months
Time frame: Baseline and 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).
5 secondary outcomes
Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months
Time frame: Baseline and 12 Months
Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders
Time frame: 12 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months
Time frame: Baseline and 12 Months
EQ-5D Change From Baseline to 12 Months
Time frame: Baseline and 12 Months
Adverse Events
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26915009King 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.
- Background: PubMed 27668131van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick M Azar, M.D. principal investigator
Campbell Clinic
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nSTRIDE APS and Saline in people with Osteoarthritis, run by Zimmer Biomet at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months (time frame: Baseline and 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02905240, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.