Clinical Research Directory

Inclusion Criteria: * Unilateral, unstable and/or displaced distal radius AO/OTA type 2R3C fracture. * Standard treatment would consist of open reduction internal fixation (ORIF) with plate(s) and screws using a volar approach * Surgical visit occurs within 2 weeks of injury. * No radiographic evidence of fracture healing prior to surgical treatment. * Male or female, greater than 21 years of age * Subject living independently and ambulatory at the time of injury. * Subject, and/or subject's representatives are able and willing to provide informed consent and HIPAA authorization. * Subject able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests. Intra-Operative Inclusion Criteria: * No sign of active infection at the planned operative site. * Surgeons will decide whether the fracture site is a good candidate for TN-MFF use once the site is open and they can visualize the bone and surrounding soft tissue. Exclusion Criteria: * Significant ligamentous disruption requiring independent repair * Other fractures of the carpal bones or injured limb (Note: an associated ulnar styloid fracture is not exclusionary) * Pathological fracture related to an underlying malignancy * Open fractures * A previous fracture in the injured bone within the last 12 months * Presence of other orthopaedic implant in the injured bone * Patients with presumptive diagnosis of named nerve or blood vessel injury * Current infection (either superficial or deep) at the planned operative site * Sepsis within one week from the planned index procedure * History of radiotherapy to the area * Active chemotherapy treatment * Patients receiving treatment with biologics for systemic inflammatory disease (e.g., Enbrel) * Physically or mentally compromised and unable to provide consent or perform functional examinations * Subject has a condition with anticipated survival shorter than 12 months