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

This study is currently recruiting participants.
Verified March 2013 by Orthopedic Foot and Ankle Center, Ohio
Sponsor:
Collaborator:
Artimplant AB
Information provided by (Responsible Party):
Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier:
NCT01237613
First received: September 16, 2010
Last updated: March 28, 2013
Last verified: March 2013
History of Changes

September 16, 2010
March 28, 2013
November 2010
July 2013   (final data collection date for primary outcome measure)
  • The Foot Function Index (FFI) for evaluation of foot pain and disability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The Foot Function Index (FFI) for evaluation of foot pain and disability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The Foot Function Index (FFI) for evaluation of foot pain and disability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • General measure of health-related quality of life using the EuroQoL (EQ-5D) questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Range of motion, strength and calf circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Subjective evaluation of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Return to work and previous physical activities [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Clinical evaluation including adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The American Orthopaedic Foot and Ankle Society (AOFAS) clinical rating system for ankle-hindfoot [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • General measure of health-related quality of life using the EuroQoL (EQ-5D) questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Range of motion, strength and calf circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Subjective evaluation of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Return to work and previous physical activities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical evaluation including adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The American Orthopaedic Foot and Ankle Society (AOFAS) clinical rating system for ankle-hindfoot [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • General measure of health-related quality of life using the EuroQoL (EQ-5D) questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Range of motion, strength and calf circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Subjective evaluation of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Return to work and previous physical activities [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical evaluation including adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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: Open Label
Primary Purpose: Treatment
Achilles Tendon Rupture
Device: Artelon
Artelon Tissue Reinforcement
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
July 2013
July 2013   (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.
Both
18 Years and older
No
Contact: Emily T Stansbury, BA 614-895-2424 stansburyet@orthofootankle.com
United States
 
NCT01237613
KP027ext
No
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
March 2013

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