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

Not Applicable

Terminated

• Conditions: Achilles Tendon Rupture
• Interventions: Device: Artelon

• Registration Number: NCT01237613
• Lead Sponsor: Orthopedic Foot and Ankle Center, Ohio

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-16
• Study Start: 2010-11
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Results First Submitted: 2015-05-08
• Results First Submitted QC: 2015-05-08
• Results First Posted: 2015-05-27
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Artelon	Artelon	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.

Primary Outcome Measures

Name	Time	Method
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability	12 months

Secondary Outcome Measures

Name	Time	Method
Clinical Evaluation Including Adverse Events	12 months
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot	12 months
Subjective Evaluation of Treatment	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
Return to Work and Previous Physical Activities	12 months

Trial Locations

Locations (1)

Orthopedic Foot and Ankle Center; 🇺🇸 Westerville, Ohio, United States