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

Orthopedic Foot & Ankle Center

Status: Terminated

Conditions: Achilles Tendon Rupture

Treatments: Device: Artelon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01237613

KP027ext

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Artelon

Experimental group

Description:

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.

Treatment:

Device: Artelon