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Completed

NCT Number: NCT01773226

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

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.

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Key information

Conditions

Gonarthrosis Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Anna Hospital

Geldrop, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Protein Solution "APS(TM)"

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2013
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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