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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gonarthrosis
Knee Osteoarthritis
Osteoarthritis
Intervention Device: Autologous Protein Solution "APS(TM)"
Enrollment 11
Recruitment Details Single-centre study in the Netherlands. FPI April 2013.
Pre-assignment Details All patients treated with APS who had at least 1 post-injection assessment of clinical outcomes were to be included in the clinical outcomes population, which was used for the clinical outcomes summaries and listings
Arm/Group Title Autologous Protein Solution "APS(TM)"
Hide Arm/Group Description

Patients who have been treated with a single, intra-articular injection.

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

Period Title: Overall Study
Started 11
Completed 10 [1]
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
Withdrawal of one subject after one-month assessment due to persistent OA symptoms
Arm/Group Title Autologous Protein Solution "APS(TM)"
Hide Arm/Group Description

Patients who have been treated with a single, intra-articular injection.

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

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  81.8%
>=65 years
2
  18.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
57  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
4
  36.4%
Male
7
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 11 participants
11
1.Primary Outcome
Title Number of Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
In cases where a patient reported multiple occurrences of an AE, the first occurrence of the worst reported case of the event was to be used for the purpose of analysis.
Arm/Group Title Autologous Protein Solution "APS(TM)"
Hide Arm/Group Description:

Patients who have been treated with a single, intra-articular injection.

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

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Adverse Events (AEs)
22
2.Secondary Outcome
Title Number of Patients Using Rescue Medication
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The incidence of patients using rescue medication for OA pain.
Arm/Group Title Autologous Protein Solution "APS(TM)"
Hide Arm/Group Description:

Patients who have been treated with a single, intra-articular injection.

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

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Frequency of Patients using Rescue medic
Injection visit 2
Month 6 2
3.Secondary Outcome
Title Pain Score
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.
Arm/Group Title Autologous Protein Solution "APS(TM)"
Hide Arm/Group Description:

Patients who have been treated with a single, intra-articular injection.

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

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: Scores on a WOMAC pain scale
Baseline 12  (1.6)
Week 1 8.2  (5.1)
Week 2 6.5  (4.7)
Month 1 4.5  (4.1)
Month 3 3.0  (3.1)
Month 6 3.1  (4.3)
4.Secondary Outcome
Title Stiffness Score
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.
Arm/Group Title Autologous Protein Solution "APS(TM)"
Hide Arm/Group Description:

Patients who have been treated with a single, intra-articular injection.

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

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: Scores on a WOMAC stiffness scale
Baseline 4.9  (0.9)
Week 1 3.8  (1.7)
Week 2 3.1  (1.2)
Month 1 2.5  (1.8)
Month 3 1.7  (1.8)
Month 6 2.3  (1.9)
5.Secondary Outcome
Title Physical Function Score
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.
Arm/Group Title Autologous Protein Solution "APS(TM)"
Hide Arm/Group Description:

Patients who have been treated with a single, intra-articular injection.

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

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: Scores on a WOMAC functionality scale
Baseline 38.1  (7.5)
Week 1 27.8  (16.2)
Week 2 21.9  (13.4)
Month 1 17.5  (15.1)
Month 3 10  (11.4)
Month 6 12.3  (14.7)
Time Frame AEs were recorded at each visit (Week 1, Week 2, Month 1, Month 3, Month 6)
Adverse Event Reporting Description In cases where a patient reported multiple occurrences of an AE, the first occurrence of the worst reported case of the event was to be used for the purpose of analysis.
 
Arm/Group Title Autologous Protein Solution "APS(TM)"
Hide Arm/Group Description

Patients who have been treated with a single, intra-articular injection.

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

All-Cause Mortality
Autologous Protein Solution "APS(TM)"
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Autologous Protein Solution "APS(TM)"
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Autologous Protein Solution "APS(TM)"
Affected / at Risk (%) # Events
Total   9/11 (81.82%)    
Gastrointestinal disorders   
Tootache  1  1/11 (9.09%)  1
General disorders   
Fatigue  1  1/11 (9.09%)  1
Site Discomfort  1  1/11 (9.09%)  1
Injection site joint pain  1  1/11 (9.09%)  1
Malaise  1  1/11 (9.09%)  1
Injury, poisoning and procedural complications   
Procedural Nausea  1  1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders   
Joint effusion  1  6/11 (54.55%)  7
Arthralgia  1  3/11 (27.27%)  4
Joint stiffness  1  3/11 (27.27%)  3
Joint instability  1  2/11 (18.18%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA® version 16.1
  1. Small sample size
  2. Unblinded observational study
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Linda Korthout, Scientific Affairs Specialist
Organization: Zimmer Biomet
Phone: +31.610.072.853
EMail: Linda.Korthout.external@zimmerbiomet.com
Layout table for additonal information
Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01773226    
Other Study ID Numbers: APSS-11-00
First Submitted: January 7, 2013
First Posted: January 23, 2013
Results First Submitted: March 22, 2016
Results First Posted: June 15, 2016
Last Update Posted: February 5, 2018