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This study has been withdrawn prior to enrollment.
(Funding withdrawn)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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014