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

• Conditions: M17.0; M17.1; M17.4; M17.5; Primary gonarthrosis, bilateral; Other primary gonarthrosis; Other secondary gonarthrosis, bilateral; Other secondary gonarthrosis

• Registration Number: DRKS00010478
• Lead Sponsor: ORTHOGEN AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraindividual comparison of the pain sub scale of the Knee injury and Osteoarthritis Outcome Score (KOOS) between week 0 and 48 weeks.

Secondary Outcome Measures

Name	Time	Method
1) Intraindividual comparison of the Numeric Rating Scale (NRS) between week 0 and 48 weeks.<br>2) Intraindividual comparison of the sub-scales of the Knee injury and Osteoarthritis Outcome Score (KOOS) between week 0 and 48 weeks.<br>3) Intraindividual comparison of the EuroQol five dimensions questionnaire15 (EQ-5D) between week 0 and 48 weeks.<br>4) Intraindividual comparison of the Work Productivity and Activity Impairment (WPAI) between week 0 and 48 weeks.<br>