Acute Achilles Repair With or Without OrthADAPT Augmentation

Not Applicable

Withdrawn

• Conditions: Achilles Tendon Tear
• Interventions: Device: Achilles repair with OrthADAPT augmentation; Procedure: Achilles repair without OrthADAPT Augmentation

• Registration Number: NCT00962143
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-08-17
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Achilles repair with OrthADAPT augmentation	Achilles repair with OrthADAPT augmentation	Achilles repair with OrthADAPT augmentation
Achilles repair without OrthADAPT Augmentation	Achilles repair without OrthADAPT Augmentation	Achilles repair without OrthADAPT Augmentation

Primary Outcome Measures

Name	Time	Method
Time to return to weight bearing	2, 3, 4.5, 6, and 12 months
Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb	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

Name	Time	Method
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
Swelling, stiffness, pain, disease specific quality of life: SF-36, AOFAS Hindfoot scores	6 weeks, 2, 3, 4.5, 6 and 12 months

Trial Locations

Locations (1)

Orthopaedic Institute of Central Jersey; 🇺🇸 Sea Girt, New Jersey, United States