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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773226
• Other study ID #: APSS-11-00
• Status: Completed
• Phase: N/A
• First received: January 7, 2013
• Last updated: January 8, 2018
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2018
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gonarthrosis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Netherlands	St. Anna Hospital	Geldrop

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months post-injection
Secondary	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.	Up to 6 months post-injection
Secondary	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.	Baseline, Week 1, Week 2, and at Months 1, 3, and 6.
Secondary	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.	Baseline, Week 1, Week 2, and at Months 1, 3, and 6.
Secondary	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.	Baseline, Week 1, Week 2, and at Months 1, 3, and 6.