This is a post-market study to evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation. The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites are involved. The study duration will be Approximately 36 months (6 months start-up, 1 year enrollment, 1 year follow-up, 6 months closeout/study report).
Background: The INTERTAN nail was designed to improve upon existing intramedullary nail systems. INTERTAN nails utilize two interlocking screws, thereby improving controlled intertochanteric fracture compression and post-surgical stability. Purpose: Evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation Objectives: * Primary Objective: To evaluate the revision rate for any reason of femoral fractures, treated with INTERTAN 10S Nails at one year post-operation * Secondary Objective: To generate safety and effectiveness evidence for INTERTAN 10S Nails via the collection of functional outcomes, quality of life, and safety data Research participants / locations: The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites in China are involved.
Study Type
OBSERVATIONAL
Femoral fracture treated with INTERTAN 10S Nail
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tang Shan 2rd Hospital
Tangshan, Hebei, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
The Revision Rate
To evaluate the revision rate for any reason of femoral fractures, treated with INTERTAN 10S Nails at one year post-operation.
Time frame: 1 year
Intraoperative Complications
Documentation of any complications related to the implantation of the device. Potential complications of this type of surgery include, but are not limited to, those listed below. * Loosening, bending, cracking or fracture of the implant components * Limb shortening or loss of anatomical position, accompanied with bone nonunion or with rotation or angulated malunion * Infections, both deep and superficial * Irritational injury of soft tissues, including impingement syndrome * Supracondylar fractures from retrograde nailing * Macrophage and foreign body reactions adjacent to implants
Time frame: Intraoperative
Radiographic Assessment
Full-length standing radiographs, standard anteroposterior (AP), and lateral radiographs of lower extremities taken prior to surgery and at all follow-up time points to identify the presence of bone healing result, normal fracture healing and disturbed fracture healing.
Time frame: Pre-operative, 6 weeks, 3 months, 6 months, & 1 year
Time to Union
To evaluate the bone healing during each visit by achieving radiographic union.
Time frame: Through study completion, approximately 1 year
Harris Hip Score (HHS)
The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).
Time frame: 6 weeks, 3 months, 6 months, & 1 year
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Peking University Third Hospital
Beijing, China
Shanghai 6th People Hospital
Shanghai, China
Shanghai Tenth People's Hospital
Shanghai, China
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measurement of health outcome. It consists of a descriptive system with 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned five levels (no problems, slight problems, moderate problems, severe problems and extreme problems), as well as, a Visual Analogue Scale (VAS) where subjects indicate a numerical value from 1-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the dimensions. This decision results in a 1- digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.
Time frame: Pre-operative, 6 weeks, 3 months, 6 months, & 1 year
Time to Return to Full Weight-Bearing
To evaluate the bone healing during each visit by achieving return to full weight-bearing.
Time frame: Post-operatively through study completion, approximately 12 months
Length of Stay
Length of stay in days participant spends in hospital.
Time frame: During hospitalization