Comparison of Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation for the Treatment of Closed Unstable Trochanteric Fractures - A Randomized-controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hip Fractures
- Sponsor
- AO Clinical Investigation and Publishing Documentation
- Enrollment
- 251
- Locations
- 9
- Primary Endpoint
- Mobility measured with the "timed up & go"-test during hospital stay.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mobility measured with the "timed up & go"-test during hospital stay.
Time Frame: 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 Outcomes
- Local adverse events and revision rate(one year)
- Functional independence(1 week prior to operation)
- Pain(one year)
- Mortality(one year)
- Walking ability(one year)
- Systemic adverse events(one year)
- Timed up & go-test at follow-ups(one year)
- Quality of life(one year)
- Fracture risk prior to injury(1 week prior to operation)
- Description of surgical details as surgery time and fluoroscopy time, and of augmentation details (PFNA Augmentation group only).(Intraoperative)
- Duration of hospital stay(one year)
- Return to pre-fracture residential status(one year)
- Implant migration(one year)
- Comorbidity(1 week prior to operation)