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: July 15, 2014
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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:
  • Total Number of Adverse Events [ Time Frame: Up to 6 months post-injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pain, stiffness, and function [ Time Frame: 0, 1, 2, 4, 13, 26 wks ] [ Designated as safety issue: No ]
  • Number of patients using rescue medication [ Time Frame: Up to 6 months post-injection ] [ Designated as safety issue: No ]

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)
Groups/Cohorts Assigned Interventions
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with OA of the knee who have failed conservative OA

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

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01773226     History of Changes
Other Study ID Numbers: APSS-11-00
Study First Received: January 7, 2013
Last Updated: July 15, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014