Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy

Study Overview
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Brief Summary
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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

Detailed Description
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Overuse injury of the Achilles tendon is a common entity. When the exact origin of tendon pain is unclear, the term tendinopathy is preferred. Most accepted treatment at this moment is an eccentric exercise programme, according to the Dutch guidelines. However, a recent systematic review on the effectiveness of eccentric exercises to treat lower extremity tendinoses concluded that it is unclear whether eccentric exercises are more effective than other forms of treatment. Recent studies described new treatment strategies in tendinopathies, such as the use autologous Tenocyte Implantation (ATI). This treatment option can participate actively in tissue repair processes on cell level. The only published clinical pilot study in tendon research reported 60% improvement in all scores after 6 months follow-up.

Official Title
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The Value of Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy: a Double-blind Randomised Clinical Trial

Conditions
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Tendinopathy, Achilles Tendon Injury, Achillodynia

Intervention / Treatment
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* Other: Autologous Tenocyte Implantation
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Tenocyte Implantation<br>Intratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises | Other: Autologous Tenocyte Implantation<br>* Intratendinous ATI (autologous tenocyte injection) with eccentric exercises<br>|
| Placebo Comparator: Saline injection<br>Intratendinous saline injection with eccentric exercises | Other: Saline<br>* Intratendinous saline injection with eccentric exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VISA-A score | a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous tenocytes, cell therapy, eccentric exercises