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Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy (ATI)

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ClinicalTrials.gov Identifier: NCT01343836
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : February 16, 2015
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Tendinopathy Achilles Tendon Injury Achillodynia Other: Autologous Tenocyte Implantation Other: Saline Phase 2 Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Value of Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy: a Double-blind Randomised Clinical Trial
Study Start Date : April 2011
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Autologous Tenocyte Implantation
Intratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises
Other: Autologous Tenocyte Implantation
Intratendinous ATI (autologous tenocyte injection) with eccentric exercises
Placebo Comparator: Saline injection
Intratendinous saline injection with eccentric exercises
Other: Saline
Intratendinous saline injection with eccentric exercises

Outcome Measures

Primary Outcome Measures :
  1. VISA-A score [ Time Frame: 24 weeks ]
    a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy

Secondary Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343836

Sports medicine department Medical Center The Hague
Leidschendam, Zuid-Holland, Netherlands, 2262 BA
Sponsors and Collaborators
Erasmus Medical Center
Principal Investigator: J.A.N. Verhaar, Prof Erasmus Medical Center
Principal Investigator: P.L.J. van Veldhoven, MD Medical Center The Hague
More Information

Responsible Party: Prof J.A.N. Verhaar, Prof. J.A.N. Verhaar, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01343836     History of Changes
Other Study ID Numbers: METC10-102
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by Prof J.A.N. Verhaar, Erasmus Medical Center:
autologous tenocytes
cell therapy
eccentric exercises

Additional relevant MeSH terms:
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases
Wounds and Injuries