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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Artelon Tissue Reinforcement
Orthopedic Foot and Ankle Center
Westerville, Ohio, United States
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
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
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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