Acute Achilles Repair With or Without OrthADAPT Augmentation

Achilles Tendon Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00962143
• Other study ID #: P07-044-CR
• Status: Withdrawn
• Phase: N/A
• First received: August 17, 2009
• Last updated: April 4, 2017
• Start date: June 2008
• Est. completion date: January 2011

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendon Tear

Intervention

Device:
• Achilles repair with OrthADAPT augmentation
Achilles repair with OrthADAPT augmentation

Procedure:
• Achilles repair without OrthADAPT Augmentation
Achilles repair without OrthADAPT Augmentation

Locations

Country	Name	City	State
United States	Orthopaedic Institute of Central Jersey	Sea Girt	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Synovis Surgical Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb		2, 3, 4.5, 6, and 12 months
Primary	Time to return to weight bearing		2, 3, 4.5, 6, and 12 months
Primary	Time to return to full activity		2, 3, 4.5, 6, and 12 months
Secondary	Swelling, stiffness, pain, disease specific quality of life: SF-36, AOFAS Hindfoot scores		6 weeks, 2, 3, 4.5, 6 and 12 months
Secondary	Complication rate including re-rupture and incision wound healing delay		6 weeks, 2, 3, 4.5, 6 and 12 months
Secondary	Incidence of device and procedure-related adverse events		6 weeks, 2, 3, 4.5, 6 and 12 months