E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic midportion Achilles tendinopathy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000433 |
E.1.2 | Term | Achilles tendinitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000435 |
E.1.2 | Term | Achilles tendon injury |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048602 |
E.1.2 | Term | Achilles tendon discomfort |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050471 |
E.1.2 | Term | Achilles tendon pain |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This study is designed to compare the treatment of 2 groups: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises. |
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E.2.2 | Secondary objectives of the trial |
To evaluate safety of the use of autologous tenocytes injection in patients with chronic midportion Achilles tendinopathy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Clinical diagnosis "chronic midportion Achilles tendinopathy" Age 18-55 years |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome: 1. VISA-A questionnaire: this is a validated instrument specifically designed to evaluate the severity of symptoms (pain and function) in patients with Achilles tendinopathy.
Secundary outcomes: 2. Ultrasonographic Tissue Characterization (UTC): The UTC method is primarily designed for evaluating equine tendons, where “real-time” consecutive transverse ultrasound images are stored on a computer. Thereafter, the tendon can be evaluated in 3 "planes of view" and the stability of the ultrasound pattern can be quantified. Using in vitro studies of isolated equine tendons, it was demonstrated that stability of the ultrasound pattern is highly indicative for the (ultra) structural integrity of the tendon tissue. Various histopathological stages (7 tissues) could be discriminated with a high significance. In the Erasmus Medical Centre, a study is already set up to determine the value of UTC during follow-up of patients with Achilles tendinopathy who are performing eccentric exercises. An effective tool for the diagnosis and management of tendon injuries could contribute to the development of new or improved capabilities in the field of early diagnosis, prevention and in particular the therapeutic area. Measurements made by the UTC that are carried out: 1. maximum AP diameter; 2. distance of the lesion from insertion; 3. lesion type (I-IV); 4. percentage intact collagen bundles.
3. Subjective patient satisfaction: the 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.
4. 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LAST VISIT OF LAST SUBJECT IN THE STUDY. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |