nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

Not Applicable

• Conditions: Osteoarthritis, Knee
• Interventions: Device: Synvisc-One; Device: nSTRIDE APS

• Registration Number: NCT03182374
• Lead Sponsor: Zimmer Biomet

Brief Summary

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 62 months; 60 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Study Start: 2017-07-14
• Primary Completion: 2019-09-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 246

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Synvisc-One	Synvisc-One	Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee
nSTRIDE APS	nSTRIDE APS	The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms.

Primary Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
Change From Baseline to 12 Months Post-injection in Mean NRS Pain Scale in Both Arms of the Study (nSTRIDE APS and Synvisc One)	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
Number or Participants Achieving Clinical Success as Defined by OMERACT-OARSI Responder Criteria in Both Arms of the Study (nSTRIDE APS and Synvisc One)	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: 1. pain ≥20% and absolute change ≥10; 2. function ≥20% and absolute change ≥10; 3. patient's global assessment ≥20% and absolute change ≥10. A positive answer here is understood as "Response". A negative answer is a "No response"
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)	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.
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	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.
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	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.

Trial Locations

Locations (14)

Yildirim Beyazit University, School of Medicine; 🇹🇷 Ankara, Turkey

The Parker Institute, Frederiksberg Hospital; 🇩🇰 Copenhagen, Denmark

Praxiskliniek für Unfallchirurgie und Orthopädie; 🇩🇪 Eisenach, Germany

KniePraxis; 🇩🇪 Straubing, Germany

Rizzoli Orthopedic Institute; 🇮🇹 Bologna, Italy

The Istituto Clinico Humanitas; 🇮🇹 Milano, Italy

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Madrid, Spain

Royal Infirmary of Edinburgh - NHS Lothian; 🇬🇧 Edinburgh, United Kingdom

AZ Monica; 🇧🇪 Antwerp, Belgium

Ospedale Regionale di Lugano; 🇨🇭 Lugano, Switzerland

Gloucestershire Hospitals NHS Foundation Trust; 🇬🇧 Cheltenham, United Kingdom

Maastricht UMC+; 🇳🇱 Maastricht, Netherlands

Oslo University Hospital - Olympiatoppen; 🇳🇴 Oslo, Norway