Acute Achilles Repair With or Without OrthADAPT Augmentation

Study Overview
=================
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.

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

Conditions
-----------------
Achilles Tendon Tear

Intervention / Treatment
-----------------
* Device: Achilles repair with OrthADAPT augmentation
* Procedure: Achilles repair without OrthADAPT Augmentation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Achilles repair without OrthADAPT Augmentation<br>Achilles repair without OrthADAPT Augmentation | Procedure: Achilles repair without OrthADAPT Augmentation<br>* Achilles repair without OrthADAPT Augmentation<br>|
| Experimental: Achilles repair with OrthADAPT augmentation<br>Achilles repair with OrthADAPT augmentation | Device: Achilles repair with OrthADAPT augmentation<br>* Achilles repair with OrthADAPT augmentation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Achilles Tendon Tear, Acute Achilles Tendon Repair