Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Eccentric Exercise in Treatment of Achilles Tendinopathy

NCT03089008

Achillodynia

COMPLETED NA

A Study Examining Changes in Pain After Manual Therapy in People With Achilles Tendon Pain

NCT06134856

Achilles Tendinopathy Ankle Strain Achilles Tendon Pain +1 more

COMPLETED NA

Micronized dHACM Injectable for the Treatment of Achille Tendonitis

NCT03414255

Tendonitis;Achilles

COMPLETED PHASE3

Autologous Stem Cells in Achilles Tendinopathy

NCT02064062

Achilles Tendinitis, Right Leg Achilles Tendinitis Achilles Degeneration +3 more

UNKNOWN PHASE2

The Effect of Collagen Scaffold Augmentation in Achilles Tendon Rupture Repair

NCT07130357

Achilles Tendon Rupture

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tendinopathy Achilles Tendon Injury Achillodynia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Autologous Tenocyte Implantation

Intratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises

Group Type EXPERIMENTAL

Autologous Tenocyte Implantation

Intervention Type OTHER

Intratendinous ATI (autologous tenocyte injection) with eccentric exercises

Saline injection

Intratendinous saline injection with eccentric exercises

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Intratendinous saline injection with eccentric exercises

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autologous Tenocyte Implantation

Intratendinous ATI (autologous tenocyte injection) with eccentric exercises

Intervention Type OTHER

Saline

Intratendinous saline injection with eccentric exercises

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No