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

Primary Purpose

Tendinopathy, Achilles Tendon Injury, Achillodynia

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Autologous Tenocyte Implantation
Saline
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring autologous tenocytes, cell therapy, eccentric exercises

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sports medicine department Medical Center The Hague

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Autologous Tenocyte Implantation

Saline injection

Arm Description

Intratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises

Intratendinous saline injection with eccentric exercises

Outcomes

Primary Outcome Measures

VISA-A score
a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy

Secondary Outcome Measures

Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC)
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
Subjective patient satisfaction
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.
Returning to sports level
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.

Full Information

First Posted
April 27, 2011
Last Updated
February 12, 2015
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01343836
Brief Title
Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy
Acronym
ATI
Official Title
The Value of Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy: a Double-blind Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Achilles Tendon Injury, Achillodynia
Keywords
autologous tenocytes, cell therapy, eccentric exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Tenocyte Implantation
Arm Type
Experimental
Arm Description
Intratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises
Arm Title
Saline injection
Arm Type
Placebo Comparator
Arm Description
Intratendinous saline injection with eccentric exercises
Intervention Type
Other
Intervention Name(s)
Autologous Tenocyte Implantation
Intervention Description
Intratendinous ATI (autologous tenocyte injection) with eccentric exercises
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Intratendinous saline injection with eccentric exercises
Primary Outcome Measure Information:
Title
VISA-A score
Description
a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC)
Description
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
Time Frame
24 weeks
Title
Subjective patient satisfaction
Description
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.
Time Frame
24 weeks
Title
Returning to sports level
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.A.N. Verhaar, Prof
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
P.L.J. van Veldhoven, MD
Organizational Affiliation
Medical Center The Hague
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sports medicine department Medical Center The Hague
City
Leidschendam
State/Province
Zuid-Holland
ZIP/Postal Code
2262 BA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21495863
Citation
Chen J, Yu Q, Wu B, Lin Z, Pavlos NJ, Xu J, Ouyang H, Wang A, Zheng MH. Autologous tenocyte therapy for experimental Achilles tendinopathy in a rabbit model. Tissue Eng Part A. 2011 Aug;17(15-16):2037-48. doi: 10.1089/ten.TEA.2010.0492. Epub 2011 Jun 10.
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Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy

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