Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hip Fractures Closed Fracture of Hip |
Device: PFNA Augmentation (Synthes) Device: PFNA (Synthes) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial |
- Mobility measured with the "timed up & go"-test during hospital stay. [ Time Frame: 5 to 7 days postoperative ] [ Designated as safety issue: No ]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.
- Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only). [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
- Pain [ Time Frame: one year ] [ Designated as safety issue: No ]Pain, measured with the Numerical Rating Scale (NRS) and use of pain medication postoperative.
- Duration of hospital stay [ Time Frame: one year ] [ Designated as safety issue: No ]
- Walking ability [ Time Frame: one year ] [ Designated as safety issue: No ]Parker Mobility Score
- Return to pre-fracture residential status [ Time Frame: one year ] [ Designated as safety issue: No ]
- Timed up & go-test at follow-ups [ Time Frame: one year ] [ Designated as safety issue: No ]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 [ Time Frame: one year ] [ Designated as safety issue: No ]EuroQol-5D
- Local adverse events and revision rate [ Time Frame: one year ] [ Designated as safety issue: No ]Implant / surgery, bone / fracture, soft tissue of the musculoskeletal system, wound related adverse events
- Systemic adverse events [ Time Frame: one year ] [ Designated as safety issue: No ]
- Implant migration [ Time Frame: one year ] [ Designated as safety issue: No ]Measured at the CT in a subgroup only
- Mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
- Fracture risk prior to injury [ Time Frame: 1 week prior to operation ] [ Designated as safety issue: No ]Measured with the Fracture Risk Assessment Tool (FRAX)
- Functional independence [ Time Frame: 1 week prior to operation ] [ Designated as safety issue: No ]Measured with the Barthel Index
- Comorbidity [ Time Frame: 1 week prior to operation ] [ Designated as safety issue: No ]Charlson Comorbidiy Index
| Estimated Enrollment: | 144 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: PFNA
Proximal Femoral Nail Antirotation (PFNA Synthes)
|
Device: PFNA (Synthes)
Proximal Femoral Nail Antirotation (PFNA)
Other Names:
|
|
Active Comparator: PFNA Augmentation
Proximal Femoral Nail Antirotation (PFNA Synthes) Augmentation (with Traumacem V+ Synthes)
|
Device: PFNA Augmentation (Synthes)
Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 75 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Jan Ljungqvist | +41 44 200 24 61 | jan.ljungqvist@aofoundation.org |
| Austria | |
| Medical University of Innsbruck | Recruiting |
| Innsbruck, Austria, 6020 | |
| Contact: Christian Kammerlander, MD +43 512 504 80882 Christian.Kammerlander@uki.at | |
| Belgium | |
| KUL Univ. Ziekenhuizen Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: An Sermon, MD an.sermon@uzleuven.be | |
| Germany | |
| BGU Tübingen | Recruiting |
| Tübingen, Germany, 72076 | |
| Contact: Dankward Höntzsch, MD | |
| Contact: Matthias Baumann, MD | |
| University of Ulm | Recruiting |
| Ulm, Germany, 89075 | |
| Contact: Florian Gebhard, MD florian.gebhard@uniklinik-ulm.de | |
| Sophien und Hufeland Klinikum GmbH | Recruiting |
| Weimar, Germany, 99425 | |
| Contact: Olaf Bach, MD O.Bach@Klinikum-Weimar.de | |
| Israel | |
| Hadassah Medical Organization | Not yet recruiting |
| Jerusalem, Israel, 91120 | |
| Contact: Yoram Weill, MD WeilY@hadassah.org.il | |
| Norway | |
| Sykehuset i Vestfold HF Tønsberg | Recruiting |
| Tønsberg, Norway, 3103 | |
| Contact: Sturla Hem, MD einhehe@online.no | |
| Switzerland | |
| Cantonal Hospital Lucerne | Recruiting |
| Lucerne, Switzerland, 6000 | |
| Contact: Reto Babst, MD reto.babst@ksl.ch | |
| City Hospital Waid | Recruiting |
| Zürich, Switzerland, 8037 | |
| Contact: Christoph Meier, MD christoph.meier@waid.zuerich.ch | |
| Study Director: | Beate P. Hanson, MD | AO Clinical Investigation and Documentation, Davos, Switzerland |
| Principal Investigator: | Christian Kammerlander, MD | Medical University of Innsbruck, Austria |
More Information
No publications provided
| Responsible Party: | AO Clinical Investigation and Documentation |
| ClinicalTrials.gov Identifier: | NCT01473082 History of Changes |
| Other Study ID Numbers: | PFNA augmented |
| Study First Received: | November 10, 2011 |
| Last Updated: | April 26, 2013 |
| Health Authority: | Austria: Ethikkommission Belgium: Ethics Committee Germany: Ethics Commission Israel: Ethics Commission Norway: Ethics Committee Switzerland: Ethikkommission |
Additional relevant MeSH terms:
|
Fractures, Bone Fractures, Closed Hip Fractures Wounds and Injuries |
Femoral Fractures Hip Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 16, 2013