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

NCT01237613 | Terminated Results

• 1 other identifier: KP027ext
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendon Rupture

Keywords

Achilles; Rupture; Tendon; Artelon

Outcome Measures

Primary Outcomes (3)

• The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability

  3 months

• The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability

  6 months

• The Foot Function Index (FFI) for Evaluation of Foot Pain and Disability

  12 months

Secondary Outcomes (18)

• The American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System for Ankle-hindfoot

  3 months

• 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

• Subjective Evaluation of Treatment

  3 months

• Return to Work and Previous Physical Activities

  3 months

Study Arms (1)

Artelon

EXPERIMENTAL

This is 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.

Device: Artelon

Interventions

Artelon DEVICE

Artelon Tissue Reinforcement

Artelon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orthopedic Foot and Ankle Center, Ohio: lead
• Artimplant AB: collaborator

Study Sites (1)

Orthopedic Foot and Ankle Center

Westerville, Ohio, 43082, United States

Location

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

The sample size is small due to the study being terminated early because of sponsor bankrupty,

Results Point of Contact

• Title: Terrence M. Philbin, DO
• Organization: Orthopedic Foot and Ankle Center

ofacresearch@orthofootankle.com

614-895-8747

Study Officials

• Terrence M Philbin, DO

  Orthopedic Foot and Ankle Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: November 9, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 22, 2015
• Results First Posted: May 27, 2015

Record last verified: 2015-06

Locations

US (1)