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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFNA | Active Comparator | Proximal Femoral Nail Antirotation (PFNA Synthes) |
|
| PFNA Augmentation | Active Comparator | Proximal Femoral Nail Antirotation PFNA Augmentation (Synthes) with Traumacem V+ Synthes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFNA Augmentation (Synthes) | Device | Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 to 7 days postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only). | Intraoperative | |
| Pain | Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Faeh | AO Clinical Investigation and Documentation, Davos, Switzerland | Study Director |
| Christian Kammerlander, MD | Medical University of Innsbruck, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Innsbruck | 6020 | Austria | |||
| KUL Univ. Ziekenhuizen Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29724590 | Result | Kammerlander C, Hem ES, Klopfer T, Gebhard F, Sermon A, Dietrich M, Bach O, Weil Y, Babst R, Blauth M. Cement augmentation of the Proximal Femoral Nail Antirotation (PFNA) - A multicentre randomized controlled trial. Injury. 2018 Aug;49(8):1436-1444. doi: 10.1016/j.injury.2018.04.022. Epub 2018 Apr 22. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| PFNA (Synthes) | Device | Proximal Femoral Nail Antirotation (PFNA) |
|
|
| one year |
| Duration of hospital stay | one year |
| Walking ability | Parker Mobility Score | one year |
| Return to pre-fracture residential status | 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. | one year |
| Quality of life | EuroQol-5D | one year |
| Local adverse events and revision rate | Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events | one year |
| Systemic adverse events | one year |
| Implant migration | Measured at the CT in a subgroup only | one year |
| Mortality | one year |
| Fracture risk prior to injury | Measured with the Fracture Risk Assessment Tool (FRAX) | 1 week prior to operation |
| Functional independence | Measured with the Barthel Index | 1 week prior to operation |
| Comorbidity | Charlson Comorbidiy Index | 1 week prior to operation |
| Leuven |
| 3000 |
| Belgium |
| BGU Tübingen | Tübingen | 72076 | Germany |
| University of Ulm | Ulm | 89075 | Germany |
| Sophien und Hufeland Klinikum GmbH | Weimar | 99425 | Germany |
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
| Sykehuset i Vestfold HF Tønsberg | Tønsberg | 3103 | Norway |
| Cantonal Hospital Lucerne | Lucerne | 6000 | Switzerland |
| City Hospital Waid | Zurich | 8037 | Switzerland |
| D007869 |
| Leg Injuries |