Acute Achilles Repair With or Without OrthADAPT Augmentation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Achilles Tendon Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Achilles repair without OrthADAPT Augmentation

Group Type ACTIVE_COMPARATOR

Achilles repair without OrthADAPT Augmentation

Intervention Type PROCEDURE

Achilles repair without OrthADAPT Augmentation

Achilles repair with OrthADAPT augmentation

Group Type EXPERIMENTAL

Achilles repair with OrthADAPT augmentation

Intervention Type DEVICE

Achilles repair with OrthADAPT augmentation

Interventions

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Achilles repair with OrthADAPT augmentation

Intervention Type DEVICE

Achilles repair without OrthADAPT Augmentation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No