Clinical trial NCT00962143: Acute Achilles Repair With or Without OrthADAPT Augmentation
Official title: Prospective, Randomized, Multi-center: Acute Achilles Repair With or Without OrthADAPT Augmentation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Achilles Tendon Tear
Keywords: Acute Achilles Tendon Tear
Acute Achilles Tendon Repair
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Synovis Surgical Innovations
First posted: 2009-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb
timeFrame: 2, 3, 4.5, 6, and 12 months
measure: Time to return to weight bearing
timeFrame: 2, 3, 4.5, 6, and 12 months
measure: Time to return to full activity
timeFrame: 2, 3, 4.5, 6, and 12 months
Secondary outcomes:
measure: Swelling, stiffness, pain, disease specific quality of life: SF-36, AOFAS Hindfoot scores
timeFrame: 6 weeks, 2, 3, 4.5, 6 and 12 months
measure: Complication rate including re-rupture and incision wound healing delay
timeFrame: 6 weeks, 2, 3, 4.5, 6 and 12 months
measure: Incidence of device and procedure-related adverse events
timeFrame: 6 weeks, 2, 3, 4.5, 6 and 12 months
Other outcomes:
Locations:
city: Sea Girt
country: United States
facility: Orthopaedic Institute of Central Jersey
state: New Jersey
Study officials:
affiliation: Department of Orthopaedic Surgery, UCSD
name: Daniel Lee, DPM
role: PRINCIPAL_INVESTIGATOR
References: