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.

Study Overview

• Status: Terminated
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Device: Artelon

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Westerville, Ohio, United States, 43082
      • Orthopedic Foot and Ankle Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Artelon; Artelon Tissue Reinforcement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Orthopedic Foot and Ankle Center, Ohio
• Collaborators: Artimplant AB
• Investigators: Principal Investigator: Terrence M Philbin, DO, Orthopedic Foot and Ankle Center

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: September 16, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (ESTIMATE): November 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 22, 2015
• Last Update Submitted That Met QC Criteria: June 29, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Achilles; Rupture; Tendon; Artelon
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: KP027ext