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

Stopped early · Not applicable

Conditions studied: Achilles Tendon Rupture

In brief

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.

Key facts

Study ID

NCT01237613

Run by

Orthopedic Foot and Ankle Center, Ohio

People needed

4

Starts

2010-11-01

Expected to finish

2014-02-01

Last updated by the study team

2015-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Orthopedic Foot and Ankle Center — Westerville, Ohio, United States

Full record on ClinicalTrials.gov

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