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

Primary Purpose

Achilles Tendon Rupture

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artelon
Sponsored by
Orthopedic Foot and Ankle Center, Ohio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring Achilles, Rupture, Tendon, Artelon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Orthopedic Foot and Ankle Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artelon

Arm 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.

Outcomes

Primary Outcome Measures

The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability

Secondary Outcome Measures

The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Range of Motion, Strength and Calf Circumference
Subjective Evaluation of Treatment
Return to Work and Previous Physical Activities
Clinical Evaluation Including Adverse Events
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Range of Motion, Strength and Calf Circumference
Subjective Evaluation of Treatment
Return to Work and Previous Physical Activities
Clinical Evaluation Including Adverse Events
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Range of Motion, Strength and Calf Circumference
Subjective Evaluation of Treatment
Return to Work and Previous Physical Activities
Clinical Evaluation Including Adverse Events

Full Information

First Posted
September 16, 2010
Last Updated
June 29, 2015
Sponsor
Orthopedic Foot and Ankle Center, Ohio
Collaborators
Artimplant AB
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1. Study Identification

Unique Protocol Identification Number
NCT01237613
Brief Title
Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
Official Title
Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Sponsoring company declared bankrupty
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopedic Foot and Ankle Center, Ohio
Collaborators
Artimplant AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
Achilles, Rupture, Tendon, Artelon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artelon
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Artelon
Intervention Description
Artelon Tissue Reinforcement
Primary Outcome Measure Information:
Title
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
Time Frame
3 months
Title
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
Time Frame
6 months
Title
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
Time Frame
3 months
Title
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Time Frame
3 months
Title
Range of Motion, Strength and Calf Circumference
Time Frame
3 months
Title
Subjective Evaluation of Treatment
Time Frame
3 months
Title
Return to Work and Previous Physical Activities
Time Frame
3 months
Title
Clinical Evaluation Including Adverse Events
Time Frame
3 months
Title
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
Time Frame
6 months
Title
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Time Frame
6 months
Title
Range of Motion, Strength and Calf Circumference
Time Frame
6 months
Title
Subjective Evaluation of Treatment
Time Frame
6 months
Title
Return to Work and Previous Physical Activities
Time Frame
6 months
Title
Clinical Evaluation Including Adverse Events
Time Frame
6 months
Title
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
Time Frame
12 months
Title
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
Time Frame
12 months
Title
Range of Motion, Strength and Calf Circumference
Time Frame
12 months
Title
Subjective Evaluation of Treatment
Time Frame
12 months
Title
Return to Work and Previous Physical Activities
Time Frame
12 months
Title
Clinical Evaluation Including Adverse Events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence M Philbin, DO
Organizational Affiliation
Orthopedic Foot and Ankle Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Foot and Ankle Center
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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