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

Achilles Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01237613
• Other study ID #: KP027ext
• Status: Terminated
• Phase: N/A
• First received: September 16, 2010
• Last updated: June 29, 2015
• Start date: November 2010
• Est. completion date: February 2014

Study information

• Verified date: June 2015
• Source: Orthopedic Foot and Ankle Center, Ohio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Device:
• Artelon
Artelon Tissue Reinforcement

Locations

Country	Name	City	State
United States	Orthopedic Foot and Ankle Center	Westerville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Orthopedic Foot and Ankle Center, Ohio	Artimplant AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability		3 months	No
Primary	The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability		6 months	No
Primary	The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability		12 months	No
Secondary	The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot		3 months	No
Secondary	General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire		3 months	No
Secondary	Range of Motion, Strength and Calf Circumference		3 months	No
Secondary	Subjective Evaluation of Treatment		3 months	No
Secondary	Return to Work and Previous Physical Activities		3 months	No
Secondary	Clinical Evaluation Including Adverse Events		3 months	No
Secondary	The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot		6 months	No
Secondary	General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire		6 months	No
Secondary	Range of Motion, Strength and Calf Circumference		6 months	No
Secondary	Subjective Evaluation of Treatment		6 months	No
Secondary	Return to Work and Previous Physical Activities		6 months	No
Secondary	Clinical Evaluation Including Adverse Events		6 months	No
Secondary	The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot		12 months	No
Secondary	General Measure of Health-related Quality of Life Using the EuroQoL (EQ-5D) Questionnaire		12 months	No
Secondary	Range of Motion, Strength and Calf Circumference		12 months	No
Secondary	Subjective Evaluation of Treatment		12 months	No
Secondary	Return to Work and Previous Physical Activities		12 months	No
Secondary	Clinical Evaluation Including Adverse Events		12 months	No