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

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02905240
• Collaborator: (none)
• Enrollment: 332
• Locations: 27
• Arms: 2
• Duration (Months): 43
• Patients Per Site: 12.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Nov 1, 2016
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nSTRIDE APS Autologous Protein Solution prepared using the nSTRIDE APS Kit	Device: nSTRIDE APS; single intra-articular injection; Other Names: Autologous Protein Solution
Other: Saline Saline control	Device: Saline; single intra-articular injection

Outcome Measures

Primary Outcome Measures

1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale [12 months]

   Pain scores measured utilizing patient surveys

Secondary Outcome Measures

1. Visual Analog Scale (VAS) Pain [12 months]

   Change in pain as measured by VAS pain

2. Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders [12 months]

   Percentage of OMERACT-OARSI responders

3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale [12 months]

   Stiffness scores measured utilizing patient surveys

4. EQ-5D [12 months]

   Change in quality of life utilizing patient surveys

5. Adverse Events [12 months]

   Frequency of adverse events of interest

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	AVANT Research Associates, LLC	Guntersville	Alabama	United States	35976
3	Tucson Orthopaedic Institute, PC	Tucson	Arizona	United States	85712
4	CORE Orthopaedic Medical Center	Encinitas	California	United States	92024
5	University of California at Los Angeles	Los Angeles	California	United States	90095
6	University of California, San Francisco	San Francisco	California	United States	94158
7	Andrews Research and Education Foundation (AREF)	Gulf Breeze	Florida	United States	32561
8	Florida Hospital Orthopaedic Institute and Fracture Care Center	Orlando	Florida	United States	32804
9	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida	United States	33409
10	Orthoillinois, Ltd.	Rockford	Illinois	United States	61114
11	Orthopedic & Sports Medicine Center	Elkhart	Indiana	United States	46514
12	OrthoIndy	Greenwood	Indiana	United States	46143
13	Kansas University Medical Center Research Institute, Inc.	Kansas City	Kansas	United States	66160
14	Brigham and Women's Mass General Health Care Center	Foxboro	Massachusetts	United States	02035
15	Northwell Health - Great Neck	Great Neck	New York	United States	11021
16	Northwell Health - Lenox Hill	New York	New York	United States	10065
17	Duke University Medical Center	Durham	North Carolina	United States	27710
18	Wake Forest School of Medicine	Winston-Salem	North Carolina	United States	27157
19	University of Cincinnati College of Medicine	Cincinnati	Ohio	United States	45229
20	Ohio State University	Columbus	Ohio	United States	43221
21	Joint Implant Surgeons, Inc	New Albany	Ohio	United States	43054
22	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
23	The Campbell Foundation	Germantown	Tennessee	United States	38138
24	Baylor College of Medicine	Houston	Texas	United States	77030
25	Texas Center for Joint Replacement	Plano	Texas	United States	75093
26	University of Virginia	Charlottesville	Virginia	United States	22903
27	OrthoVirginia	Richmond	Virginia	United States	23294

Sponsors and Collaborators

• Zimmer Biomet

Investigators

• Principal Investigator: Frederick M Azar, M.D., Campbell Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• King W, van der Weegen W, Van Drumpt R, Soons H, Toler K, Woodell-May J. White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution. J Exp Orthop. 2016 Dec;3(1):9. doi: 10.1186/s40634-016-0043-7. Epub 2016 Feb 9.
• van Drumpt RA, van der Weegen W, King W, Toler K, Macenski MM. Safety and Treatment Effectiveness of a Single Autologous Protein Solution Injection in Patients with Knee Osteoarthritis. Biores Open Access. 2016 Aug 1;5(1):261-8. doi: 10.1089/biores.2016.0014. eCollection 2016.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT02905240
• Other Study ID Numbers: APSS-44-00
• First Posted: Sep 19, 2016
• Last Update Posted: Nov 10, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Zimmer Biomet: Autologous Protein Solution; APS; intra-articular injection; osteoarthritis
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 10, 2020