Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy

Tendinopathy Clinical Trial

— ATI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343836
• Other study ID #: METC10-102
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 27, 2011
• Last updated: February 12, 2015
• Start date: April 2011
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achilles Tendon Injury
• Achillodynia
• Tendinopathy
• Tendon Injuries

Intervention

Other:
• Autologous Tenocyte Implantation
Intratendinous ATI (autologous tenocyte injection) with eccentric exercises
• Saline
Intratendinous saline injection with eccentric exercises

Locations

Country	Name	City	State
Netherlands	Sports medicine department Medical Center The Hague	Leidschendam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VISA-A score	a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy	24 weeks	No
Secondary	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	24 weeks	No
Secondary	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.	24 weeks	No
Secondary	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.	24 weeks	No