nSTRIDE APS Versus Hyaluronic Acid for Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03182374
• Other study ID #: APSS-66-00
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 14, 2017
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 246
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• nSTRIDE APS
Intra-articular injection
• Synvisc-One
Intra-articular injection

Locations

Country	Name	City	State
Belgium	AZ Monica	Antwerp
Denmark	The Parker Institute, Frederiksberg Hospital	Copenhagen
Germany	Praxiskliniek für Unfallchirurgie und Orthopädie	Eisenach
Germany	KniePraxis	Straubing
Italy	Rizzoli Orthopedic Institute	Bologna
Italy	The Istituto Clinico Humanitas	Milano
Netherlands	Maastricht UMC+	Maastricht
Norway	Oslo University Hospital - Olympiatoppen	Oslo
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Madrid
Switzerland	Ospedale Regionale di Lugano	Lugano
Turkey	Yildirim Beyazit University, School of Medicine	Ankara
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust	Cheltenham
United Kingdom	Royal Infirmary of Edinburgh - NHS Lothian	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

Belgium,  Denmark,  Germany,  Italy,  Netherlands,  Norway,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing Autologous Protein Solution (APS) with Hyaluronic Acid (HA) Intra Articular Injections	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 pain score	12 months
Secondary	NRS pain scale	Change in pain as measured by NRS pain scale	12 months
Secondary	OMERACT-OARSI	Percentage of subjects achieving clinical success as defined by OMERACT-OARSI Responder Criteria	12 months
Secondary	WOMAC LK 3.1	Change in WOMAC LK 3.1 function, stiffness subscale and overall scores	12 months
Secondary	EQ-5D	Change in quality of life	12 months
Secondary	Adverse Events (AEs)	Occurrence of AEs	12 months