Acute Achilles Repair With or Without OrthADAPT Augmentation

Withdrawn before enrolling · Not applicable

Conditions studied: Achilles Tendon Tear

In brief

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.

Key facts

Study ID

NCT00962143

Run by

Baxter Healthcare Corporation

People needed

0

Starts

2008-06-01

Expected to finish

2011-01-01

Last updated by the study team

2017-04-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.