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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01237613

Enrollment

Registered

2010-11-09

Start date

2010-11-30

Completion date

2014-02-28

Last updated

2015-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendon Rupture

Keywords

Achilles, Rupture, Tendon, Artelon

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.

Interventions

DEVICEArtelon

Artelon Tissue Reinforcement

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability	3 months

Secondary

Measure	Time frame
General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire	3 months
Range of Motion, Strength and Calf Circumference	3 months
The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot	3 months
Return to Work and Previous Physical Activities	3 months
Clinical Evaluation Including Adverse Events	3 months
Subjective Evaluation of Treatment	3 months

Countries

United States

Participant flow

Participants by arm

Arm	Count
Artelon This was 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	4
Total	4

Baseline characteristics

Characteristic	Artelon
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	4 Participants
Age, Continuous	54 years
Region of Enrollment United States	4 participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	2 / 4
serious Total, serious adverse events	0 / 4