Efficacy and safety of autologous conditioned serum (ACS/Orthokine®) compared with Triamcinolone in the treatment of symptomatic hip osteoarthritis.

Completed

• Conditions: Osteoarthritis of the hip; Musculoskeletal Diseases; Coxarthrosis

• Registration Number: ISRCTN16719506
• Lead Sponsor: Orthogen AG (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Age: over 30 years old
2. Chronic hip osteoarthritic (OA) 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 hip joint (Kellgren 2 or 3; Ravaud & Dougados 1997)
4. Signed written informed consent
5. At least pain grade 4 (measured on a numeric rating scale 0-10)

Exclusion Criteria

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

2. Treatment:
2.1. Treatment of the affected hip due to osteoarthritis with one of the two study medications in the last 6 months
2.2. Present psychiatric disease requiring therapy
2.3. Ongoing corticoid or non-steroidal anti-inflammatory drug (NSAID) therapy due to other diseases

3. Other:
3.1. Operation on the affected hip within the last 3 months
3.2. Pregnant or breast-feeding patients
3.3. Drug dependency (alcohol, analgesics, opiates, etc.)
3.4. 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
1. Mean changes from baseline in the global Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC) score<br>2. Changes in weight-bearing pain using a numeric rating scale (NRS)<br>All questionnaires will be filled out as a baseline score before the visit, right after the last of three injections, after 3 months and after 6 months.

Secondary Outcome Measures

Name	Time	Method
1. Success of therapies measured according to the changes from baseline in the different health-related quality-of-life profiles<br>1.1. SF-12<br>1.2. Harris Hip Score <br>1.3. EuroCol-5d <br>2. The number of adverse events and serious adverse events wil be used to compare the safety profile of the two treatments groups. <br>All questionnaires will be filled out as a baseline score before the visit, right after the last of three injections, after 3 months and after 6 months.