NCT01343836

Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tendinopathy
• Achilles Tendon Injury
• Achillodynia

Interventions

Type	Name	Description
OTHER	Autologous Tenocyte Implantation	Intratendinous ATI (autologous tenocyte injection) with eccentric exercises
OTHER	Saline	Intratendinous saline injection with eccentric exercises

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2011-04-28
• Last updated: 2015-02-16

Locations

1 site across 1 country: Netherlands