Clinical trial NCT01237613: Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
Official title: Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Achilles
Rupture
Tendon
Artelon
Lead sponsor: Orthopedic Foot and Ankle Center, Ohio
Sponsor class: OTHER
Collaborators: name: Artimplant AB
First posted: 2010-11-09
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
timeFrame: 3 months
measure: The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
timeFrame: 6 months
measure: The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability
timeFrame: 12 months
Secondary outcomes:
measure: The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
timeFrame: 3 months
measure: General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
timeFrame: 3 months
measure: Range of Motion, Strength and Calf Circumference
timeFrame: 3 months
measure: Subjective Evaluation of Treatment
timeFrame: 3 months
measure: Return to Work and Previous Physical Activities
timeFrame: 3 months
measure: Clinical Evaluation Including Adverse Events
timeFrame: 3 months
measure: The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
timeFrame: 6 months
measure: General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
timeFrame: 6 months
measure: Range of Motion, Strength and Calf Circumference
timeFrame: 6 months
measure: Subjective Evaluation of Treatment
timeFrame: 6 months
measure: Return to Work and Previous Physical Activities
timeFrame: 6 months
measure: Clinical Evaluation Including Adverse Events
timeFrame: 6 months
measure: The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot
timeFrame: 12 months
measure: General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire
timeFrame: 12 months
measure: Range of Motion, Strength and Calf Circumference
timeFrame: 12 months
measure: Subjective Evaluation of Treatment
timeFrame: 12 months
measure: Return to Work and Previous Physical Activities
timeFrame: 12 months
measure: Clinical Evaluation Including Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Westerville
country: United States
facility: Orthopedic Foot and Ankle Center
state: Ohio
Study officials:
affiliation: Orthopedic Foot and Ankle Center
name: Terrence M Philbin, DO
role: PRINCIPAL_INVESTIGATOR
References: