Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-01-01 @ 10:14 AM
Study NCT ID:
NCT02074969
Status:
COMPLETED
Last Update Posted:
2014-03-03
First Post:
2014-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures
Sponsor:
Medical University of Vienna
Organization:
Study Overview
Official Title:
Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures - Epidemiological Data and Rates of Complications
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: