Acute Achilles Repair With or Without OrthADAPT Augmentation

This study has been withdrawn prior to enrollment.
(Funding withdrawn)
Sponsor:
Information provided by:
Synovis Surgical Innovations
ClinicalTrials.gov Identifier:
NCT00962143
First received: August 17, 2009
Last updated: December 12, 2012
Last verified: December 2009
  Purpose

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.


Condition Intervention
Achilles Tendon Tear
Device: Achilles repair with OrthADAPT augmentation
Procedure: Achilles repair without OrthADAPT Augmentation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Multi-center: Acute Achilles Repair With or Without OrthADAPT Augmentation

Further study details as provided by Synovis Surgical Innovations:

Primary Outcome Measures:
  • Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb [ Time Frame: 2, 3, 4.5, 6, and 12 months ] [ Designated as safety issue: No ]
  • Time to return to weight bearing [ Time Frame: 2, 3, 4.5, 6, and 12 months ] [ Designated as safety issue: No ]
  • Time to return to full activity [ Time Frame: 2, 3, 4.5, 6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Swelling, stiffness, pain, disease specific quality of life: SF-36, AOFAS Hindfoot scores [ Time Frame: 6 weeks, 2, 3, 4.5, 6 and 12 months ] [ Designated as safety issue: No ]
  • Complication rate including re-rupture and incision wound healing delay [ Time Frame: 6 weeks, 2, 3, 4.5, 6 and 12 months ] [ Designated as safety issue: No ]
  • Incidence of device and procedure-related adverse events [ Time Frame: 6 weeks, 2, 3, 4.5, 6 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Achilles repair without OrthADAPT Augmentation
Achilles repair without OrthADAPT Augmentation
Procedure: Achilles repair without OrthADAPT Augmentation
Achilles repair without OrthADAPT Augmentation
Experimental: Achilles repair with OrthADAPT augmentation
Achilles repair with OrthADAPT augmentation
Device: Achilles repair with OrthADAPT augmentation
Achilles repair with OrthADAPT augmentation

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962143

Locations
United States, New Jersey
Orthopaedic Institute of Central Jersey
Sea Girt, New Jersey, United States, 08750
Sponsors and Collaborators
Synovis Surgical Innovations
Investigators
Principal Investigator: Daniel Lee, DPM Department of Orthopaedic Surgery, UCSD
  More Information

No publications provided

Responsible Party: Kristi Winterfeldt, Clinical Affairs Manager, Synovis Surgical Innovations
ClinicalTrials.gov Identifier: NCT00962143     History of Changes
Other Study ID Numbers: P07-044-CR
Study First Received: August 17, 2009
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Synovis Surgical Innovations:
Acute Achilles Tendon Tear
Acute Achilles Tendon Repair

ClinicalTrials.gov processed this record on April 23, 2014