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

This study is currently recruiting participants.

Verified March 2013 by Orthopedic Foot and Ankle Center, Ohio

Sponsor:

Collaborator:

Artimplant AB

Information provided by (Responsible Party):

Orthopedic Foot and Ankle Center, Ohio

ClinicalTrials.gov Identifier:

NCT01237613

First received: September 16, 2010

Last updated: March 28, 2013

Last verified: March 2013

History of Changes

Purpose

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.

Condition	Intervention
Achilles Tendon Rupture	Device: Artelon

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon

Resource links provided by NLM:

MedlinePlus related topics: Foot Health

U.S. FDA Resources

Further study details as provided by Orthopedic Foot and Ankle Center, Ohio:

Primary Outcome Measures:

The Foot Function Index (FFI) for evaluation of foot pain and disability [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The Foot Function Index (FFI) for evaluation of foot pain and disability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The Foot Function Index (FFI) for evaluation of foot pain and disability [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The American Orthopaedic Foot and Ankle Society (AOFAS) clinical rating system for ankle-hindfoot [ Time Frame: 3 months ] [ Designated as safety issue: No ]
General measure of health-related quality of life using the EuroQoL (EQ-5D) questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Range of motion, strength and calf circumference [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Subjective evaluation of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Return to work and previous physical activities [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Clinical evaluation including adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The American Orthopaedic Foot and Ankle Society (AOFAS) clinical rating system for ankle-hindfoot [ Time Frame: 6 months ] [ Designated as safety issue: No ]
General measure of health-related quality of life using the EuroQoL (EQ-5D) questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Range of motion, strength and calf circumference [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Subjective evaluation of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Return to work and previous physical activities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinical evaluation including adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The American Orthopaedic Foot and Ankle Society (AOFAS) clinical rating system for ankle-hindfoot [ Time Frame: 12 months ] [ Designated as safety issue: No ]
General measure of health-related quality of life using the EuroQoL (EQ-5D) questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Range of motion, strength and calf circumference [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Subjective evaluation of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Return to work and previous physical activities [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Clinical evaluation including adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	November 2010
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Artelon Tissue Reinforcement

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient has a clinically confirmed isolated chronic rupture or rerupture of the Achilles tendon.
The patient has been informed about the study and signed the patient consent form.
The patient reads, understands and is able to complete the study questionnaires in English.

Exclusion Criteria:

The patient has an ongoing infection of the soft tissues of the ankle.
The patient has evidence of severe ankle arthritis.
The patient has a multi-system or multi-limb trauma.
The patient has a major medical condition that would affect quality of life and influence the results of the study.
The patient is pregnant
The patient is not expected to complete the study according to the investigation plan.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237613

Contacts

Contact: Emily T Stansbury, BA

614-895-2424

stansburyet@orthofootankle.com

Locations

United States, Ohio
Orthopedic Foot and Ankle Center	Recruiting
Westerville, Ohio, United States, 43082
Principal Investigator: Terrence M Philbin, DO

Sponsors and Collaborators

Orthopedic Foot and Ankle Center, Ohio

Artimplant AB

Investigators

Principal Investigator:

Terrence M Philbin, DO

Orthopedic Foot and Ankle Center

More Information

No publications provided

Responsible Party:	Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier:	NCT01237613 History of Changes
Other Study ID Numbers:	KP027ext
Study First Received:	September 16, 2010
Last Updated:	March 28, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Orthopedic Foot and Ankle Center, Ohio:

Achilles
Rupture
Tendon
Artelon

Additional relevant MeSH terms:

Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013

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