The value of Autologous Tenocyte Implantation in patients with chronic Achilles tendinopathy: a double-blind randomised clinical trial - ATI in Achilles tendinopathy

• Conditions: Chronic midportion Achilles tendinopathy; MedDRA version: 12.1Level: LLTClassification code 10000433Term: Achilles tendinitis; MedDRA version: 12.1Level: LLTClassification code 10000435Term: Achilles tendon injury; MedDRA version: 12.1Level: LLTClassification code 10048602Term: Achilles tendon discomfort; MedDRA version: 12.1Level: LLTClassification code 10050471Term: Achilles tendon pain

• Registration Number: EUCTR2010-021869-73-NL
• Lead Sponsor: OrthoCell Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-22
• Last Update Posted: 14 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Clinical diagnosis chronic midportion Achilles tendinopathy
Age 18-55 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Clinical suspicion of insertional disorders , Achilles tendon rupture, plantar flexor tenosynovitis, sural nerve pathology, peroneal subluxation
- Condition of the Achilles tendon caused by medications such as quinolones and statins
- Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoidosis.
- Presence of an infectious disease (Hepatitis B, Hepatitis C, HIV, Syphilis)
- A condition that prevents the patients from executing an active rehabilitation programme
- Patient has received an injection in the previous 12 months for this injury
- Patient has received surgical intervention for this injury
- Patient has already one site (left or right) included in this study
- Patient does not wish, for whatever reason, to undergo one of the two treatments
- Known pregnancy
- Nursing women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified