Status:
WITHDRAWN
Acute Achilles Repair With or Without OrthADAPT Augmentation
Lead Sponsor:
Baxter Healthcare Corporation
Collaborating Sponsors:
Synovis Surgical Innovations
Conditions:
Achilles Tendon Tear
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00962143
Start Date
June 1 2008
End Date
January 1 2011
Last Update
April 5 2017
Active Locations (1)
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1
Orthopaedic Institute of Central Jersey
Sea Girt, New Jersey, United States, 08750