Achilles Tendon Injury, Achillodynia, Tendinopathy
Conditions
Keywords
autologous tenocytes, cell therapy, eccentric exercises
Brief summary
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
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.
Interventions
OTHERAutologous Tenocyte Implantation
Intratendinous ATI (autologous tenocyte injection) with eccentric exercises
OTHERSaline
Intratendinous saline injection with eccentric exercises
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VISA-A score | 24 weeks | a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC) | 24 weeks | 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 |
| Subjective patient satisfaction | 24 weeks | 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. |
| Returning to sports level | 24 weeks | 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. |
Countries
Netherlands
Outcome results
None listed