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This study has been withdrawn prior to enrollment.
(Funding withdrawn)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

August 17, 2009
December 12, 2012
June 2008
December 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00962143 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Acute Achilles Repair With or Without OrthADAPT Augmentation
Prospective, Randomized, Multi-center: Acute Achilles Repair With or Without OrthADAPT Augmentation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Achilles Tendon Tear
  • Device: Achilles repair with OrthADAPT augmentation
    Achilles repair with OrthADAPT augmentation
  • Procedure: Achilles repair without OrthADAPT Augmentation
    Achilles repair without OrthADAPT Augmentation
  • Active Comparator: Achilles repair without OrthADAPT Augmentation
    Achilles repair without OrthADAPT Augmentation
    Intervention: Procedure: Achilles repair without OrthADAPT Augmentation
  • Experimental: Achilles repair with OrthADAPT augmentation
    Achilles repair with OrthADAPT augmentation
    Intervention: Device: Achilles repair with OrthADAPT augmentation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00962143
P07-044-CR
No
Kristi Winterfeldt, Clinical Affairs Manager, Synovis Surgical Innovations
Synovis Surgical Innovations
Not Provided
Principal Investigator: Daniel Lee, DPM Department of Orthopaedic Surgery, UCSD
Synovis Surgical Innovations
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP