Fractures
Conditions
Keywords
re-operation rate, pertrochanteric fractures, GammaNail, PFNA, Tip-Apex-Distance, Parkers-Ratio
Brief summary
The purpose of this study is to assess the differences between two different types of devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).
Detailed description
This trial is a prospective randomized controlled study including the treatment of AO/OTA 31-A2 fractures in 200 patients with 2 different surgical devices. 100 patients are treated with a Gamma Nail 3 (GN3) (Stryker) the other 100 patients with a Proximal Femoral Nail Antirotation (PFNA) (Synthes). All surgeries are performed by trauma surgeons at a Level 1 University Hospital. One hundred patients are randomized to the gamma nail and 100 are randomized to the proximal femoral nail for treatment fixation. A 1:1 randomization is performed using sealed envelopes (200 in total), which are opened by the surgeon immediately before the operation. Patients missing an informed consent form, incomplete chart, or showing a pathologic fracture are getting excluded from final comparisons. Patients anthropometric data as well as pre-injury mobility assessments, and ASA will be documented. Furthermore the time from admission to going to surgery, surgery length, length of stay and mobility assessment at dischargement are recorded. After surgery the stay in the hospital is documented precisely and patients are scheduled for next appointments 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery. Postoperative X-rays are measured precisely to determine the Tip-Apex Distance (TAD), the Parkers-Ratio, the Singh-Score and the Neck-Shaft-Angle of the injured and contralateral side. Rates of complications as cut-out and reoperation-rates are evaluated. All intra-operative complications are noted and included in the chart.
Interventions
DEVICEGamma Nail 3
Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.
DEVICEPFNA
Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* AO/OTA 31-A2 fractures * age between 18 - 100 years * Signed written informed consent and agreement to attend the planned FUs * Able to understand and read country national language at an elementary level
Exclusion criteria
* missing informed consent form * pathological fracture * incomplete patient record * death within one month of intervention (surgery) * prior surgery to the hip * polytrauma * any additional fracture * any implant at the same hip * infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| re-operation rate | time between intervention and one year after |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screw-Cut Out | time between intervention and one year after | evaluation of sliding movements of the hip screw in the sense of a cut-out |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mobility assessment | time between hospitalization and one year after intervention | Mobility assessment includes scoring of pre-operative level of mobility and mobility after intervention |
Countries
Austria
Outcome results
None listed