Health Condition 1: S728- Other fracture of femur Health Condition 2: null- Patients presented with primary stable or unstable, intertrochanteric and subtrochanteric proximal femur fractures requiring surgical intervention eligible for intramedullary nailing Health Condition 3: S722- Subtrochanteric fracture of femur
Conditions
Interventions
None listed
Sponsors
Zimmer India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patient must meet the following criteria to be eligible for participation: - Age of 50 years old or above. - Diagnosed with primary stable or unstable, intertrochanteric or subtrochanteric fractures of the femur. - Required or completed surgical intervention with CM Asia or Long Nail. - Able to read, understand and sign the informed consent form. - Willing and capable of following the Investigatorâ??s instructions and complying with the follow-up visits.
Exclusion criteria
Exclusion criteria: Patient must not meet the following criteria to be eligible for participation: - A medullary canal obliterated by a previous fracture or tumor. - Bone shaft having excessive bow or deformity. - Lack of bone substance or bone quality which makes stable seating of the implant impossible. - Concomitant diseases that can impair the functioning and the success of the implant. - Infection. - Insufficient blood circulation. - Skeletally immature. - Not able to walk before the proximal fracture. - Prisoners, mentally incompetent, and/or anticipated to be non-compliant. - Revision surgery (e.g. change from failed Dynamic Hip Screw to nail). - Pathologic fractures. - Pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the proportion of implant-related complications such as lag screw cut-out and nail breakage.Timepoint: Follow-up evaluations will be performed at 6 weeks, 3, 6 and 12 months post-operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients with fracture union. - Proportion of patients with delayed fracture union, defined as visible bridging callus at a minimum of two cortices and full weight bearing without pain from 3 to 6 months after surgery. - Proportion of patients with fracture non-union, defined as no visible bridging callus at a minimum of two cortices 6 months after surgery. - Proportion of patients with Harris Hip Score (HHS) - Change in quality-of-life questionnaire EQ-5D index scoreTimepoint: Follow-up evaluations will be performed at 6 weeks, 3, 6 and 12 months post-operatively. | — |
Countries
Republic of Korea
Contacts
Public ContactThrivikram Devatha
Zimmer India Pvt. Ltd
Outcome results
None listed