Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon

Study Overview
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Brief Summary
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The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with regard to lower leg and foot function, pain and quality of life.

Official Title
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Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon

Conditions
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Achilles Tendon Rupture

Intervention / Treatment
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* Device: Artelon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has a clinically confirmed isolated chronic rupture or rerupture of the Achilles tendon. The patient has been informed about the study and signed the patient consent form. The patient reads, understands and is able to complete the study questionnaires in English. Exclusion Criteria: The patient has an ongoing infection of the soft tissues of the ankle. The patient has evidence of severe ankle arthritis. The patient has a multi-system or multi-limb trauma. The patient has a major medical condition that would affect quality of life and influence the results of the study. The patient is pregnant The patient is not expected to complete the study according to the investigation plan.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artelon<br>This is an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement. | Device: Artelon<br>* Artelon Tissue Reinforcement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability |  | 3 months | 
| The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability |  | 6 months | 
| The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot |  | 3 months | 
| General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire |  | 3 months | 
| Range of Motion, Strength and Calf Circumference |  | 3 months | 
| Subjective Evaluation of Treatment |  | 3 months | 
| Return to Work and Previous Physical Activities |  | 3 months | 
| Clinical Evaluation Including Adverse Events |  | 3 months | 
| The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot |  | 6 months | 
| General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire |  | 6 months | 
| Range of Motion, Strength and Calf Circumference |  | 6 months | 
| Subjective Evaluation of Treatment |  | 6 months | 
| Return to Work and Previous Physical Activities |  | 6 months | 
| Clinical Evaluation Including Adverse Events |  | 6 months | 
| The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot |  | 12 months | 
| General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire |  | 12 months | 
| Range of Motion, Strength and Calf Circumference |  | 12 months | 
| Subjective Evaluation of Treatment |  | 12 months | 
| Return to Work and Previous Physical Activities |  | 12 months | 
| Clinical Evaluation Including Adverse Events |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Achilles, Rupture, Tendon, Artelon