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Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)

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ClinicalTrials.gov Identifier: NCT01773226
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : June 15, 2016
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE January 7, 2013
First Posted Date  ICMJE January 23, 2013
Results First Submitted Date  ICMJE March 22, 2016
Results First Posted Date  ICMJE June 15, 2016
Last Update Posted Date February 5, 2018
Actual Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
Number of Adverse Events [ Time Frame: Up to 6 months post-injection ]
Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months.
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
Total Number of Adverse Events [ Time Frame: Up to 6 months post-injection ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
  • Number of Patients Using Rescue Medication [ Time Frame: Up to 6 months post-injection ]
    Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee.
  • Pain Score [ Time Frame: Baseline, Week 1, Week 2, and at Months 1, 3, and 6. ]
    The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.
  • Stiffness Score [ Time Frame: Baseline, Week 1, Week 2, and at Months 1, 3, and 6. ]
    Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.
  • Physical Function Score [ Time Frame: Baseline, Week 1, Week 2, and at Months 1, 3, and 6. ]
    Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
  • pain, stiffness, and function [ Time Frame: 0, 1, 2, 4, 13, 26 wks ]
  • Number of Patients Using Rescue Medication [ Time Frame: Up to 6 months post-injection ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)
Official Title  ICMJE A Prospective Single-Center Clinical Study of a Single Intra-Articular Injection of Autologous Protein Solution ("APS(TM)") in Patients With Osteoarthritis (OA) of the Knee
Brief Summary This prospective single-center study will evaluate the safety and tolerability of a single dose of "APS(TM)" treated patients with OA of the knee who have failed conservative OA therapy. The study will also evaluate efficacy by assessing patient pain and functionality.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gonarthrosis
  • Knee Osteoarthritis
  • Osteoarthritis
Intervention  ICMJE Device: Autologous Protein Solution "APS(TM)"
A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins
Study Arms  ICMJE Experimental: Autologous Protein Solution "APS(TM)"
Patients who have been treated with a single, intra-articular injection.
Intervention: Device: Autologous Protein Solution "APS(TM)"
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2014)
11
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2013)
10
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Eligibility Criteria:

  • Male or female ≥40 years.
  • Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions.
  • A standing radiograph of the knee showing a Kellgren grade of 2 or 3
  • Frequency of knee pain on most days over the last month.
  • Diagnosis of unilateral knee OA
  • Body mass index (BMI) ≤40 kg/m2.
  • Failed conservative OA therapy.
  • Signed an independent ethics committee (IEC)-approved informed consent form (ICF).
  • Willingness to abstain from the use of topical pain therapies, intra-articular corticosteroids, and viscosupplementation during the study.
  • Willingness to abstain from systemic pain medications except rescue medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01773226
Other Study ID Numbers  ICMJE APSS-11-00
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: R.A.M. van Drumpt, M.D. St. Anna Hospital, Geldrop, NL
PRS Account Zimmer Biomet
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP