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

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

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.

Inclusion Criteria:

1. The patient has a clinically confirmed isolated chronic rupture or rerupture of the Achilles tendon.
2. The patient has been informed about the study and signed the patient consent form.
3. The patient reads, understands and is able to complete the study questionnaires in English.

Exclusion Criteria:

1. The patient has an ongoing infection of the soft tissues of the ankle.
2. The patient has evidence of severe ankle arthritis.
3. The patient has a multi-system or multi-limb trauma.
4. The patient has a major medical condition that would affect quality of life and influence the results of the study.
5. The patient is pregnant
6. The patient is not expected to complete the study according to the investigation plan.