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Clinical Trials/DRKS00010478
DRKS00010478
Recruiting
Not Applicable

Prospective, open, multicentre observational clinical study to inves- tigate safety and efficacy of cell-free Autologous Conditioned Serum (ACS) in patients with knee osteoarthritis with 3 years follow-up - OrthoR

ORTHOGEN AG0 sites1,000 target enrollmentNovember 14, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
M17.0
Sponsor
ORTHOGEN AG
Enrollment
1000
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 14, 2016
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
ORTHOGEN AG

Eligibility Criteria

Inclusion Criteria

  • 1\) Confirmed Knee OA (Kellgren\-Lawrence Grades II–IV) diagnosis with imaging proceders (e.g. x\-ray, CT, MRI) not older than 6 month
  • 2\) Knee pain for at least 4 weeks and pain intensity NRS \=5
  • 3\) Treatment initiation with ACS
  • 4\) Signed informed written Patient´s Informed Consent Form

Exclusion Criteria

  • 1\) Previous knee operations in the last 6 months (Surgery and/or diagnostic arthroscopy)
  • 2\) History of clinically significant trauma
  • 3\) Intra\-articular injections in the last 3 months with steroids, hyaluronate compounds or PRP, ACS, ACP
  • 4\) RA or autoimmune cause of arthritis, systemic bone or joint illnesses
  • 5\) Active inflammation of predominant patella\-femoral disease
  • 6\) BMI\>30
  • 7\) Malignancy
  • 8\) Infection
  • 9\) Pregnancy

Outcomes

Primary Outcomes

Not specified

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