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Completed

NCT Number: NCT01343836

Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sports medicine department Medical Center The Hague

Leidschendam, South Holland, 2262 BA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Tenocyte Implantation

Other

Intratendinous ATI (autologous tenocyte injection) with eccentric exercises

Saline

Other

Intratendinous saline injection with eccentric exercises

Primary outcomes

  1. VISA-A score

    Time frame: 24 weeks

    a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy

Secondary outcomes

  1. Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC)

    Time frame: 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

  2. Subjective patient satisfaction

    Time frame: 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.

  3. Returning to sports level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: ATI

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2011
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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