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:
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: February 12, 2014
Last verified: February 2014
  Purpose

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 Intervention
Achilles Tendon Rupture
Device: Artelon

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Orthopedic Foot and Ankle Center, Ohio:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 4
Study Start Date: November 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Artelon
    Artelon Tissue Reinforcement
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier: NCT01237613     History of Changes
Other Study ID Numbers: KP027ext
Study First Received: September 16, 2010
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on April 22, 2014