The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.
To avoid the pain-causing relative movement between implant and bone, surgical techniques and devices allowing augmentation of the femoral head have recently been developed. Biomechanical studies showed that augmentation leads to a better axial stability and pull-out strength. In clinical practice, this might facilitate early mobilization and full weight-bearing with less pain. The purpose of this study is therefore to evaluate whether patients with trochanteric fractures being treated with a PFNA and augmentation can better be mobilized than patients without augmentation. In particular, it will be measured whether patients with a PFNA Augmentation can walk faster than the non-augmented patients, measured with the Timed up and Go test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
251
Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)
Proximal Femoral Nail Antirotation (PFNA)
Medical University of Innsbruck
Innsbruck, Austria
KUL Univ. Ziekenhuizen Leuven
Leuven, Belgium
BGU Tübingen
Tübingen, Germany
University of Ulm
Ulm, Germany
Mobility measured with the "timed up & go"-test during hospital stay.
The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again. Patient-perceived pain and exertion will be assessed after the test.
Time frame: 5 to 7 days postoperative
Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).
Time frame: Intraoperative
Pain
Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative.
Time frame: one year
Duration of hospital stay
Time frame: one year
Walking ability
Parker Mobility Score
Time frame: one year
Return to pre-fracture residential status
Time frame: one year
Timed up & go-test at follow-ups
The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seat position is reached again.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sophien und Hufeland Klinikum GmbH
Weimar, Germany
Hadassah Medical Organization
Jerusalem, Israel
Sykehuset i Vestfold HF Tønsberg
Tønsberg, Norway
Cantonal Hospital Lucerne
Lucerne, Switzerland
City Hospital Waid
Zurich, Switzerland
Time frame: one year
Quality of life
EuroQol-5D
Time frame: one year
Local adverse events and revision rate
Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events
Time frame: one year
Systemic adverse events
Time frame: one year
Implant migration
Measured at the CT in a subgroup only
Time frame: one year
Mortality
Time frame: one year
Fracture risk prior to injury
Measured with the Fracture Risk Assessment Tool (FRAX)
Time frame: 1 week prior to operation
Functional independence
Measured with the Barthel Index
Time frame: 1 week prior to operation
Comorbidity
Charlson Comorbidiy Index
Time frame: 1 week prior to operation