Acute Achilles Repair With or Without OrthADAPT Augmentation

Baxter

Status: Withdrawn

Conditions: Achilles Tendon Tear

Treatments: Device: Achilles repair with OrthADAPT augmentation; Procedure: Achilles repair without OrthADAPT Augmentation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00962143

P07-044-CR

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Achilles repair without OrthADAPT Augmentation

Active Comparator group

Description:

Achilles repair without OrthADAPT Augmentation

Treatment:

Procedure: Achilles repair without OrthADAPT Augmentation

Achilles repair with OrthADAPT augmentation

Experimental group

Description:

Achilles repair with OrthADAPT augmentation

Treatment:

Device: Achilles repair with OrthADAPT augmentation