Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
NCT ID: NCT01237613
Last Updated: 2015-07-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2010-11-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Artelon
Artelon Tissue Reinforcement
Interventions
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Artelon
Artelon Tissue Reinforcement
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Artimplant AB
INDUSTRY
Orthopedic Foot and Ankle Center, Ohio
OTHER
Responsible Party
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Principal Investigators
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Terrence M Philbin, DO
Role: PRINCIPAL_INVESTIGATOR
Orthopedic Foot and Ankle Center
Locations
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Orthopedic Foot and Ankle Center
Westerville, Ohio, United States
Countries
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Other Identifiers
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KP027ext
Identifier Type: -
Identifier Source: org_study_id
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