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

This study has been terminated.
(Sponsoring company declared bankrupty)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237613
First Posted: November 9, 2010
Last Update Posted: July 22, 2015
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.
Collaborator:
Artimplant AB
Information provided by (Responsible Party):
Orthopedic Foot and Ankle Center, Ohio
September 16, 2010
November 9, 2010
May 8, 2015
May 27, 2015
July 22, 2015
November 2010
February 2014   (Final data collection date for primary outcome measure)
  • The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability [ Time Frame: 3 months ]
  • The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability [ Time Frame: 6 months ]
  • The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01237613 on ClinicalTrials.gov Archive Site
  • The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot [ Time Frame: 3 months ]
  • General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire [ Time Frame: 3 months ]
  • Range of Motion, Strength and Calf Circumference [ Time Frame: 3 months ]
  • Subjective Evaluation of Treatment [ Time Frame: 3 months ]
  • Return to Work and Previous Physical Activities [ Time Frame: 3 months ]
  • Clinical Evaluation Including Adverse Events [ Time Frame: 3 months ]
  • The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot [ Time Frame: 6 months ]
  • General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire [ Time Frame: 6 months ]
  • Range of Motion, Strength and Calf Circumference [ Time Frame: 6 months ]
  • Subjective Evaluation of Treatment [ Time Frame: 6 months ]
  • Return to Work and Previous Physical Activities [ Time Frame: 6 months ]
  • Clinical Evaluation Including Adverse Events [ Time Frame: 6 months ]
  • The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot [ Time Frame: 12 months ]
  • General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire [ Time Frame: 12 months ]
  • Range of Motion, Strength and Calf Circumference [ Time Frame: 12 months ]
  • Subjective Evaluation of Treatment [ Time Frame: 12 months ]
  • Return to Work and Previous Physical Activities [ Time Frame: 12 months ]
  • Clinical Evaluation Including Adverse Events [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Achilles Tendon Rupture
Device: Artelon
Artelon Tissue Reinforcement
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.
Intervention: Device: Artelon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
February 2014
February 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01237613
KP027ext
No
Not Provided
Not Provided
Orthopedic Foot and Ankle Center, Ohio
Orthopedic Foot and Ankle Center, Ohio
Artimplant AB
Principal Investigator: Terrence M Philbin, DO Orthopedic Foot and Ankle Center
Orthopedic Foot and Ankle Center, Ohio
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP