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Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis (PROGRESS IV)

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ClinicalTrials.gov Identifier: NCT02905240
Recruitment Status : Active, not recruiting
First Posted : September 19, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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

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 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
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: nSTRIDE APS
Autologous Protein Solution prepared using the nSTRIDE APS Kit
Device: nSTRIDE APS
single intra-articular injection
Other Name: Autologous Protein Solution

Saline
Saline control
Device: Saline
single intra-articular injection
Other Name: Saline control




Primary Outcome Measures :
  1. 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 :
  1. Visual Analog Scale (VAS) Pain [ Time Frame: 12 months ]
    Change in pain as measured by VAS pain

  2. Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders [ Time Frame: 12 months ]
    Percentage of OMERACT-OARSI responders

  3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale [ Time Frame: 12 months ]
    Stiffness scores measured utilizing patient surveys

  4. EQ-5D [ Time Frame: 12 months ]
    Change in quality of life utilizing patient surveys

  5. 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


  Show 27 Study Locations
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Frederick M Azar, M.D. Campbell Clinic Orthopaedics

Publications:
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02905240     History of Changes
Other Study ID Numbers: APSS-44-00
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Zimmer Biomet:
Autologous Protein Solution
APS
intra-articular injection
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pharmaceutical Solutions