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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01237613
Recruitment Status : Terminated (Sponsoring company declared bankrupty)
First Posted : November 9, 2010
Results First Posted : May 27, 2015
Last Update Posted : July 22, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Achilles Tendon Rupture Device: Artelon

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
Study Start Date : November 2010
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health Tears
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability [ Time Frame: 3 months ]
  2. The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability [ Time Frame: 6 months ]
  3. The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot [ Time Frame: 3 months ]
  2. General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire [ Time Frame: 3 months ]
  3. Range of Motion, Strength and Calf Circumference [ Time Frame: 3 months ]
  4. Subjective Evaluation of Treatment [ Time Frame: 3 months ]
  5. Return to Work and Previous Physical Activities [ Time Frame: 3 months ]
  6. Clinical Evaluation Including Adverse Events [ Time Frame: 3 months ]
  7. The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot [ Time Frame: 6 months ]
  8. General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire [ Time Frame: 6 months ]
  9. Range of Motion, Strength and Calf Circumference [ Time Frame: 6 months ]
  10. Subjective Evaluation of Treatment [ Time Frame: 6 months ]
  11. Return to Work and Previous Physical Activities [ Time Frame: 6 months ]
  12. Clinical Evaluation Including Adverse Events [ Time Frame: 6 months ]
  13. The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot [ Time Frame: 12 months ]
  14. General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire [ Time Frame: 12 months ]
  15. Range of Motion, Strength and Calf Circumference [ Time Frame: 12 months ]
  16. Subjective Evaluation of Treatment [ Time Frame: 12 months ]
  17. Return to Work and Previous Physical Activities [ Time Frame: 12 months ]
  18. Clinical Evaluation Including Adverse Events [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237613


Locations
United States, Ohio
Orthopedic Foot and Ankle Center
Westerville, Ohio, United States, 43082
Sponsors and Collaborators
Orthopedic Foot and Ankle Center, Ohio
Artimplant AB
Investigators
Principal Investigator: Terrence M Philbin, DO Orthopedic Foot and Ankle Center
More Information

Responsible Party: Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier: NCT01237613     History of Changes
Other Study ID Numbers: KP027ext
First Posted: November 9, 2010    Key Record Dates
Results First Posted: May 27, 2015
Last Update Posted: July 22, 2015
Last Verified: June 2015

Keywords provided by Orthopedic Foot and Ankle Center, Ohio:
Achilles
Rupture
Tendon
Artelon

Additional relevant MeSH terms:
Rupture
Wounds and Injuries