Acute Achilles Repair With or Without OrthADAPT Augmentation

April 4, 2017 updated by: Baxter Healthcare Corporation

Prospective, Randomized, Multi-center: Acute Achilles Repair With or Without OrthADAPT Augmentation

The purpose of this study is to assess the clinical performance of the OrthADAPT Bioimplant in patients with acute mid-substance Achilles tendon tears requiring surgical repair.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Sea Girt, New Jersey, United States, 08750
        • Orthopaedic Institute of Central Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A transverse, full thickness, acute mid-substance Achilles tendon tear that requires surgical repair
  • Achilles tendon tear is repairable by surgery using primary means as determined by intra-operative assessment
  • Achilles tendon rupture with viable ends of the tendon that are suitable for primary repair
  • Isolated Achilles tendon rupture without poly trauma
  • Patient must be 18 to 70 years of age
  • Life expectancy greater than or equal to 12 months
  • Patient is able to provide voluntary informed consent
  • Patient is willing and able to return for all follow-up visits and study related exams
  • Patient is willing to comply with prescribed physical therapy regimen

Exclusion Criteria:

  • Emergency, poly trauma patients
  • Previous Achilles tendon surgical procedure on that tendon
  • Deficit in the contralateral extremity that prevents a comparison with the treated extremity
  • Repair requires tendon lengthening, gap filling or tendon transfer
  • BMI greater than 40
  • Peripheral arterial disease
  • Uncontrolled Diabetes Mellitis
  • Patients whose injury is known to involve litigation
  • Known allergy to equine derived product
  • Systemic collagen disease
  • Neurological disease
  • Active infection - systemic or at the intended surgical site
  • Acute use of immunosuppressive agents
  • Rupture resulting from fluoroquinolone induced tendinopathy
  • Alcohol or drug abuse
  • Participant in another investigational drug or device trial
  • Pathologic soft tissue conditions that would prevent secure surgical fixation
  • Patients who are unwilling or unable to return for follow-up visits and study related exams
  • Pregnant women
  • Cancer patients
  • Decisionally impaired patients
  • Institutionalized patients
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Achilles repair without OrthADAPT Augmentation
Procedure: Achilles repair without OrthADAPT Augmentation
Achilles repair without OrthADAPT Augmentation
Experimental: Achilles repair with OrthADAPT augmentation
Device: Achilles repair with OrthADAPT augmentation
Achilles repair with OrthADAPT augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb
Time Frame: 2, 3, 4.5, 6, and 12 months
2, 3, 4.5, 6, and 12 months
Time to return to weight bearing
Time Frame: 2, 3, 4.5, 6, and 12 months
2, 3, 4.5, 6, and 12 months
Time to return to full activity
Time Frame: 2, 3, 4.5, 6, and 12 months
2, 3, 4.5, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Swelling, stiffness, pain, disease specific quality of life: SF-36, AOFAS Hindfoot scores
Time Frame: 6 weeks, 2, 3, 4.5, 6 and 12 months
6 weeks, 2, 3, 4.5, 6 and 12 months
Complication rate including re-rupture and incision wound healing delay
Time Frame: 6 weeks, 2, 3, 4.5, 6 and 12 months
6 weeks, 2, 3, 4.5, 6 and 12 months
Incidence of device and procedure-related adverse events
Time Frame: 6 weeks, 2, 3, 4.5, 6 and 12 months
6 weeks, 2, 3, 4.5, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Collaborators

Synovis Surgical Innovations

Investigators

  • Principal Investigator: Daniel Lee, DPM, Department of Orthopaedic Surgery, UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

August 17, 2009

First Submitted That Met QC Criteria

August 18, 2009

First Posted (Estimate)

August 19, 2009

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P07-044-CR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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