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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Tenocyte Implantation | Experimental | Intratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises |
|
| Saline injection | Placebo Comparator | Intratendinous saline injection with eccentric exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Tenocyte Implantation | Other | Intratendinous ATI (autologous tenocyte injection) with eccentric exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| VISA-A score | a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy | 24 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J.A.N. Verhaar, Prof | Erasmus Medical Center | Principal Investigator |
| P.L.J. van Veldhoven, MD | Medical Center The Hague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sports medicine department Medical Center The Hague | Leidschendam | South Holland | 2262 BA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21495863 | Background | 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. |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Other | Intratendinous saline injection with eccentric exercises |
|
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 |
| D017670 |
| Sodium Compounds |