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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Achilles repair with OrthADAPT augmentation
Achilles repair without OrthADAPT Augmentation
Orthopaedic Institute of Central Jersey
Sea Girt, New Jersey, United States
Improvement in ROM and Biodex Isokinetic Strength Testing compared to contralateral limb
Time frame: 2, 3, 4.5, 6, and 12 months
Time to return to weight bearing
Time frame: 2, 3, 4.5, 6, and 12 months
Time to return to full activity
Time frame: 2, 3, 4.5, 6, and 12 months
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
Complication rate including re-rupture and incision wound healing delay
Time frame: 6 weeks, 2, 3, 4.5, 6 and 12 months
Incidence of device and procedure-related adverse events
Time frame: 6 weeks, 2, 3, 4.5, 6 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.