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

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Zimmer Biomet

Status

Completed

Conditions

Osteoarthritis
Gonarthrosis
Knee Osteoarthritis

Treatments

Device: Autologous Protein Solution "APS(TM)"

Study type

Interventional

Funder types

Industry

Identifiers

NCT01773226
APSS-11-00

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

Autologous Protein Solution "APS(TM)"
Experimental group
Description:
Patients who have been treated with a single, intra-articular injection.
Treatment:
Device: Autologous Protein Solution "APS(TM)"

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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