Closed Fracture of Hip, Hip Fractures
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPFNA Augmentation (Synthes)
Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)
DEVICEPFNA (Synthes)
Proximal Femoral Nail Antirotation (PFNA)
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 75 years and older * Closed unstable trochanteric fracture: AO 31 - A2 and A3 * Low energy trauma (e.g.fall from standing height) * Definitive fracture fixation within 72 hrs. after admission * Indication for PFNA fixation (with or without augmentation) * Ability to walk independently (walking aids are allowed) prior to injury * 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
* Pathologic fracture * Polytrauma * Any additional fracture * Open fracture * Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment * Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years * ASA class V and VI * Any implant at the same hip * Hemiplegia * Patients with legal guardian * Patients who have participated in any other device or drug related clinical trial that could influence the results of the present study within the previous month * Fractures and injuries opening into the articulation and vascular structure * Infection * Patients with clotting disorders * Patients with severe cardiac and / or pulmonary insufficiency * Patients with known hypersensitivity or allergy to any of the components of Traumacem V+ cement (Polymethyl methacrylate / acrylate, zirconium dioxide, hydroxyapatite,benzoyl peroxide, methyl methacrylate,hydroquinone, N,N-dimethyl-p-toluidine) * Perforation of the femoral head into the joint with the guide wire used for the PFNA blade * Risk of potential leakage into the joint identified by using contrast fluid (PFNA Augmentation group only) * Intraoperative decision to use implants other than PFNA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mobility measured with the timed up & go-test during hospital stay. | 5 to 7 days postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comorbidity | 1 week prior to operation | Charlson Comorbidiy Index |
| Fracture risk prior to injury | 1 week prior to operation | Measured with the Fracture Risk Assessment Tool (FRAX) |
| Functional independence | 1 week prior to operation | Measured with the Barthel Index |
| Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only). | Intraoperative | — |
| Pain | one year | Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative. |
| Duration of hospital stay | one year | — |
| Mortality | one year | — |
| Return to pre-fracture residential status | one year | — |
| Timed up & go-test at follow-ups | one year | 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. |
| Quality of life | one year | EuroQol-5D |
| Local adverse events and revision rate | one year | Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events |
| Systemic adverse events | one year | — |
| Implant migration | one year | Measured at the CT in a subgroup only |
| Walking ability | one year | Parker Mobility Score |
Countries
Austria, Belgium, Germany, Israel, Norway, Switzerland
Outcome results
None listed