Autologous conditioned serum (Orthokine®) compared with hyaluronic acid and placebo injections for the treatment of osteoarthritis. A prospective, randomized, placebo-controlled, double-blind, parallel-design, multicenter trial.

Completed

Conditions: Osteoarthitis of the knee.
Musculoskeletal Diseases
Osteoarthritis

Registration Number: ISRCTN71311752

Lead Sponsor: Orthogen (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 400

Inclusion Criteria

1. Age: over 30 years old
2. Chronic knee pain for at least 3 months measured according to American College of Rheumatology (ACR) criteria (Altman, Asch, et al. 1986)
3. X-ray signs of uni- or bi-lateral osteoarthritis of the knee joint (Kellgren 2 or 3; Ravaud & Dougados 1997)
4. Signed written informed consent
5. At least pain grade 5 (measured on a visual analogue pain scale 0-10)

Exclusion Criteria

Pathologies:
1. Systemic disease of the musculoskeletal system
2. Bone cancer, metastasis or tumor-like lesions in the immediate proximity to the treated joint
3. Fracture in the last 3 months
4. Acute bacterial infection of the knee to be treated
5. Conditions, internal or oncological, which impair the patient?s general fitness (performance status [PS] >2; New York Heart Association [NYHA] >II)
6. Blood clotting disorders
7. Osteonecrosis of the knee to be treated

Treatment:
1. Treatment of the affected knee due to osteoarthritis with one of the three study medications in the last 6 months
2. Present psychiatric disease requiring therapy
3. Ongoing corticoid therapy

Other:
1. Operation on the affected knee within the last 3 months
2. Pregnant or breast-feeding patients
3. Drug dependency (alcohol, analgesics, opiates, etc.)
4. Lack of mental ability to understand the study procedures due to lack of optimal communication capacity (knowledge of the language, dementia, lack of time)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy parameters were the mean changes from baseline in the global Western Ontario MacMaster (WOMAC) score, weight-bearing pain using a visual analogue pain scale (VAS) and global patient assessment (GPA) at weeks 13 and 26.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints were the success of therapies measured according to the changes in the different health-related quality-of-life profiles in the SF-8 with regard to baseline scores during the 26 weeks, the changes in the global patient assessment after 7 and 13 weeks and changes on the WOMAC score and the VAS pain score after 7 weeks. In addition the number of adverse events and serious adverse events was used to compare the safety profile of the three treatments groups.