Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy

Last updated: February 12, 2015
Sponsor: Erasmus Medical Center
Overall Status: Completed

Phase

2/3

Condition

Sprains

Tendon Injuries

Treatment

N/A

Clinical Study ID

NCT01343836
METC10-102
  • Ages 18-55
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pain on palpation 2-7 cm proximal from the tendon insertion ("midportion")

  • Symptoms > 2 months

  • Age 18-55 years

Exclusion

Exclusion Criteria:

  • Clinical suspicion of insertional disorders , Achilles tendon rupture, plantar flexortenosynovitis, 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 rehabilitationprogramme

  • 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

Study Design

Total Participants: 90
Study Start date:
April 01, 2011
Estimated Completion Date:
June 30, 2014

Study 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.

Connect with a study center

  • Sports medicine department Medical Center The Hague

    Leidschendam, Zuid-Holland 2262 BA
    Netherlands

    Site Not Available

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