Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy

Erasmus Medical Center90 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Tendinopathy Achilles Tendon Injury Achillodynia

Interventions

Autologous Tenocyte ImplantationOTHER

Intratendinous ATI (autologous tenocyte injection) with eccentric exercises

SalineOTHER

Intratendinous saline injection with eccentric exercises

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Sports medicine department Medical Center The Hague

Leidschendam, South Holland, Netherlands

Outcomes

Primary Outcomes

VISA-A score

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

Time frame: 24 weeks

Secondary Outcomes

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

Time frame: 24 weeks

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.

Time frame: 24 weeks

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.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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