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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01773226
First received: January 7, 2013
Last updated: May 10, 2016
Last verified: April 2014
  Purpose
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.

Condition Intervention
Gonarthrosis
Knee Osteoarthritis
Osteoarthritis
Device: Autologous Protein Solution "APS(TM)"

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: Up to 6 months post-injection ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 6 months post-injection ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 11
Study Start Date: March 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Protein Solution "APS(TM)"
Patients who have been treated with a single, intra-articular injection.
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

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773226

Locations
Netherlands
St. Anna Hospital
Geldrop, Netherlands
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: R.A.M. van Drumpt, M.D. St. Anna Hospital, Geldrop, NL
  More Information

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01773226     History of Changes
Other Study ID Numbers: APSS-11-00 
Study First Received: January 7, 2013
Results First Received: March 22, 2016
Last Updated: May 10, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Biomet, Inc.:
Autologous Protein Solution
APS
Osteoarthritis
Injection

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on December 09, 2016