Trial record 3 of 5 for:
nstride
Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis (PROGRESS IV)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02905240 |
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Recruitment Status :
Completed
First Posted : September 19, 2016
Last Update Posted : November 10, 2020
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Sponsor:
Zimmer Biomet
Information provided by (Responsible Party):
Zimmer Biomet
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis | Device: nSTRIDE APS Device: Saline | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 332 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | November 2016 |
| Actual Primary Completion Date : | July 2019 |
| Actual Study Completion Date : | June 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Osteoarthritis
MedlinePlus related topics:
Osteoarthritis
Drug Information available for:
Sodium chloride
| Arm | Intervention/treatment |
|---|---|
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Experimental: nSTRIDE APS
Autologous Protein Solution prepared using the nSTRIDE APS Kit
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Device: nSTRIDE APS
single intra-articular injection
Other Name: Autologous Protein Solution |
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Saline
Saline control
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Device: Saline
single intra-articular injection |
Primary Outcome Measures :
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale [ Time Frame: 12 months ]Pain scores measured utilizing patient surveys
Secondary Outcome Measures :
- Visual Analog Scale (VAS) Pain [ Time Frame: 12 months ]Change in pain as measured by VAS pain
- Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders [ Time Frame: 12 months ]Percentage of OMERACT-OARSI responders
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale [ Time Frame: 12 months ]Stiffness scores measured utilizing patient surveys
- EQ-5D [ Time Frame: 12 months ]Change in quality of life utilizing patient surveys
- Adverse Events [ Time Frame: 12 months ]Frequency of adverse events of interest
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905240
Locations
Show 27 study locations
Sponsors and Collaborators
Zimmer Biomet
Investigators
| Principal Investigator: | Frederick M Azar, M.D. | Campbell Clinic |
Publications:
| Responsible Party: | Zimmer Biomet |
| ClinicalTrials.gov Identifier: | NCT02905240 |
| Other Study ID Numbers: |
APSS-44-00 |
| First Posted: | September 19, 2016 Key Record Dates |
| Last Update Posted: | November 10, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Keywords provided by Zimmer Biomet:
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Autologous Protein Solution APS intra-articular injection osteoarthritis |
Additional relevant MeSH terms:
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Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |