Hip Fracture
Conditions
Keywords
hip, fracture, intertrochanteric, elderly, screw
Brief summary
Prospective, comparative, randomized, double-blind study to evaluate the outcomes of trochanteric nailing in unstable hip fractures with and without a distal interlocking screw.
Detailed description
Due to the lack of first-level evidence, this study aims to evaluate the effectiveness and safety of surgical treatment for unstable hip fractures, with or without the inclusion of a distal interlocking screw in the hip nail.
Interventions
DEVICEhip trochanteric nail
hip trochanteric nail with and without distal interlocking screw
Sponsors
Elda University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Blinding of the patient included in the study and the investigator evaluating the results
Intervention model description
Prospective, comparative, randomized and double-blind study
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient over 50 years old * With unstable intertrochanteric hip fracture * Operated in the first 48 hours after hospital admission
Exclusion criteria
* Simultaneous associated fractures * Fractures with subtrochanteric line * Non-acute fractures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of functional status using the Barthel index | 12 months | Evaluation of functional status 12 months after hip surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative mechanical complications | 12 months | Complication rate with nail, cephalic screw, or distal screw |
| Parker mobility scale | 12 months | Assessment of the patient's mobility capacity before and 12 months after hip surgery |
Countries
Spain
Contacts
Primary ContactFRANCISCO ANTONIO MIRALLES MUÑOZ
Outcome results
None listed