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Completed

NCT Number: NCT03182374

nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

This is a two-phase multicenter, double-blind, randomized, prospective evaluation of intra-articular injection(s) comparing APS to intra-articular HA injection(s). The maximum study duration for each subject will be 50 months; 48 months from treatment to last follow-up, and two additional months if the maximum visit window is realized. A total of 246 patients will be enrolled. These patients will meet specific inclusion and exclusion criteria, but can be generally characterized as patients with painful unilateral knee OA who have been unable to achieve satisfactory pain relief with previous conservative OA treatment.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Monica, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female at least 18 years of age at time of screening.
  • Willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions.
  • A standing knee radiograph showing a K-L grade of 2 to 4
  • Body mass index ≤ 40 kg/m2
  • A qualifying WOMAC LK 3.1 pain subscale total score
  • Signed an ethics committee-reviewed and approved informed consent form.

Exclusion criteria

  • Presence of clinically observed active infection in the index knee
  • Presence of symptomatic OA in the non-study knee at screening
  • 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
  • Presence of venous or lymphatic stasis in the index leg
  • A history of local anesthetic allergy
  • Previously documented failed treatment with nSTRIDE APS or Synvisc One

Treatment and study plan

nSTRIDE APS

Device

Intra-articular injection

Other names: Autologous Protein Solution

Synvisc-One

Device

Intra-articular injection

Other names: hylan G-F 20

Primary outcomes

  1. Change From Baseline to 12 Months Post-injection in Mean WOMAC LK3.1 Pain Score in Both Arms of the Study (nSTRIDE APS and Synvisc One)

    Time frame: 12 months

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5), stiffness (2), and physical function (17). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

    The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. 0 represents the best health status and 96 the worst possible status.

    This section will only analyze the WOMAC pain score.

Secondary outcomes

  1. Change From Baseline to 12 Months Post-injection in Mean NRS Pain Scale in Both Arms of the Study (nSTRIDE APS and Synvisc One)

    Time frame: 12 months

    In a Numerical Rating Scale (NRS) pain scale, patients are asked to circle (in an horizontal bar or line) the number between 0 and 10 that fits best to their average pain intensity.

    0 = No pain at all; 5 = Moderate pain; 10 = Worst possible pain

  2. Number or Participants Achieving Clinical Success as Defined by OMERACT-OARSI Responder Criteria in Both Arms of the Study (nSTRIDE APS and Synvisc One)

    Time frame: 12 months

    The Outcome Measures in Rheumatology workgroup (OMERACT), together with the Osteoarthritis Research Society International (OARSI) developed the OMERACT-OARSI responder criteria. These criteria are used to determine if a patient with osteoarthritis (OA) 'responds' to therapy, meaning experiences a clinically relevant effect of therapy.

    It includes three symptomatic domains (pain, function, and patient's global assessment).

    To the question: High improvement in pain or in function (≥50%) and absolute change ≥20%, a positive answer is understood as "Response". A negative answer leads to an additional analysis, which seeks improvement in at least 2 of the 3 following:

    • pain ≥20% and absolute change ≥10;
    • function ≥20% and absolute change ≥10;
    • patient's global assessment ≥20% and absolute change ≥10. A positive answer here is understood as "Response". A negative answer is a "No response"

  3. Change From Baseline to 12 Months Post-injection in Mean WOMAC LK 3.1 Function Subscale in Both Arms of the Study (nSTRIDE APS and Synvisc One)

    Time frame: 12 months

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5), stiffness (2), and physical function (17). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

    The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. 0 represents the best health status and 96 the worst possible status.

    This section will analyze the WOMAC Function subscale. A subject is considered an MCID Function responder if they show an absolute improvement of >= 20 points in WOMAC Function from baseline to 12 Months.

  4. Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - VAS Score

    Time frame: 12 months

    The EurpoQol five-dimensional (EQ-5D) is a standardized instrument for measuring the health-related quality of life.

    Part of the Eq-5Q questionnaire consist of a visual analogue score (VAS), a vertical calibrated line, on which a patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). Respondents indicate where they perceive their present state of health to lie, relative to these anchors.

  5. Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - Health Status Score

    Time frame: 12 months

    The EurpoQol five-dimensional (EQ-5D), section Health Status, is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety depression. Each question has five levels of response (no problem, slight problem, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score. The health status ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher score indicating higher health utility.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

A Two-Phase, Multicenter, Randomized Study Comparing Autologous Protein Solution With Hyaluronic Acid Intra Articular Injections in Patients With Knee Osteoarthritis

Important dates

Study start
2017
Primary completion
2019
Study completion
2023
First posted
Jun 9, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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