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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Erasmus Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medical Center The Hague
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01343836
First received: April 27, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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 Intervention Phase
Tendinopathy
Achilles Tendon Injury
Achillodynia
 Other: Autologous Tenocyte Implantation
Other: Saline
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • VISA-A score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy


Secondary Outcome Measures:
  • Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 90
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Tenocyte Implantation
Ultrasound guided intratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises
 Other: Autologous Tenocyte Implantation
ultrasound guided intratendinous ATI (autologous tenocyte injection) with eccentric exercises
Placebo Comparator: Saline injection
Ultrasound guided intratendinous saline injection with eccentric exercises
 Other: Saline
ultrasound guided intratendinous saline injection with eccentric 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343836

Contacts
Contact: S. de Jonge, MD +31 107044626 s.dejonge@erasmusmc.nl

Locations
Netherlands
Sports medicine department Medical Center The Hague Recruiting
Leidschendam, Zuid-Holland, Netherlands, 2262 BA
Contact: J.L. Tol, PhD, MD     +31 70 3574235     h.tol@mchaaglanden.nl    
Contact: A. Weir, MD     +31 70 3574235     a.weir@mchaaglanden.nl    
Principal Investigator: J.L. Tol, PhD, MD            
Sub-Investigator: S. de Jonge, MD            
Sponsors and Collaborators
Erasmus Medical Center
Medical Center The Hague
Investigators
Principal Investigator: J.A.N. Verhaar, Prof Erasmus Medical Center
Principal Investigator: J.L. Tol, PhD Medical Center The Hague
  More Information

Publications:

Responsible Party: Orthopaedic Department, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01343836     History of Changes
Other Study ID Numbers: METC10-102
Study First Received: April 27, 2011
Last Updated: April 27, 2011
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Erasmus Medical Center:
autologous tenocytes
cell therapy
eccentric exercises

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

ClinicalTrials.gov processed this record on May 16, 2013