Back to resultsEvaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)
Primary Purpose
Gonarthrosis, Knee Osteoarthritis, Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Autologous Protein Solution "APS(TM)"
Sponsored by
About this trial
This is an interventional treatment trial for Gonarthrosis focused on measuring Autologous Protein Solution, APS, Osteoarthritis, Injection
Eligibility Criteria
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.
Sites / Locations
- St. Anna Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Autologous Protein Solution "APS(TM)"
Arm Description
Patients who have been treated with a single, intra-articular injection.
Outcomes
Primary Outcome Measures
Number of Adverse Events
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.
Secondary Outcome Measures
Number of Patients Using Rescue Medication
Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee.
Pain Score
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01773226
Brief Title
Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonarthrosis, Knee Osteoarthritis, Osteoarthritis
Keywords
Autologous Protein Solution, APS, Osteoarthritis, Injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous Protein Solution "APS(TM)"
Arm Type
Experimental
Arm Description
Patients who have been treated with a single, intra-articular injection.
Intervention Type
Device
Intervention Name(s)
Autologous Protein Solution "APS(TM)"
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
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.
Time Frame
Up to 6 months post-injection
Secondary Outcome Measure Information:
Title
Number of Patients Using Rescue Medication
Description
Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee.
Time Frame
Up to 6 months post-injection
Title
Pain Score
Description
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.
Time Frame
Baseline, Week 1, Week 2, and at Months 1, 3, and 6.
Title
Stiffness Score
Description
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.
Time Frame
Baseline, Week 1, Week 2, and at Months 1, 3, and 6.
Title
Physical Function Score
Description
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.
Time Frame
Baseline, Week 1, Week 2, and at Months 1, 3, and 6.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R.A.M. van Drumpt, M.D.
Organizational Affiliation
St. Anna Hospital, Geldrop, NL
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Anna Hospital
City
Geldrop
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26915009
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of Intra-articular Injection of Autologous Protein Solution ("APS(TM)") for the Treatment of Osteoarthritis (OA)
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