Tendinopathy Clinical Trial
— ATIOfficial title:
The Value of Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy: a Double-blind Randomised Clinical Trial
This study is designed to compare the treatment of 2 groups in patients with Achilles tendinopathy: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises
Status | Completed |
Enrollment | 90 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Pain on palpation 2-7 cm proximal from the tendon insertion ("midportion") - Symptoms > 2 months - Age 18-55 years 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. - Antibiotics allergy (aminoglycoside group) - A condition that prevents the patients from executing an active rehabilitation programme - Patient has received an injection 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Sports medicine department Medical Center The Hague | Leidschendam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center |
Netherlands,
Chen J, Yu Q, Wu B, Lin Z, Pavlos NJ, Xu J, Ouyang H, Wang A, Zheng MH. Autologous tenocyte therapy for experimental Achilles tendinopathy in a rabbit model. Tissue Eng Part A. 2011 Aug;17(15-16):2037-48. doi: 10.1089/ten.TEA.2010.0492. Epub 2011 Jun 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VISA-A score | a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy | 24 weeks | No |
Secondary | Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC) | UTC provides quantitative information on tendon fiber alignment and the related ultra-structural integrity of the tendon tissue through a non-invasive approach and is used in several clinical trials in humans | 24 weeks | No |
Secondary | Subjective patient satisfaction | Patient satisfaction will be determined by asking the patient how satisfied he/she is with the effect of the treatment in 4 possible categories: excellent / good / moderate / poor. The groups "excellent" and "good" will be regarded as successful and the groups of "moderate" and "poor" as not successful. | 24 weeks | No |
Secondary | Returning to sports level | The patient will be asked whether they are able to return to their sports level. It is a subdivision in 5 groups: A. No sports; B. No return in sports; C. Returning in sports but not in desired sport; D. Returning in desired sport, but not yet old level; E. Returning to old level in desired sport. | 24 weeks | No |
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