PHILOS Augmented - a Multicenter Randomized Controlled Trial
Study Details
Study Description
Brief Summary
The primary objective is to compare the mechanical failure risks in the first year after treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Biomechanical tests have shown that augmentation of screws or nails with polymethylmethacrylate (PMMA) leads to increased mechanical properties of the bone-implant complex, leading to the assumption that augmentation could reduce mechanical failures in patients. While a few clinical studies have already been performed with augmented trochanteric nails in proximal femur fractures, no clinical studies exist with the use of Proximal Humerus Internal Locking System (PHILOS) and (PMMA) augmentation for the treatment of fractures in the proximal humerus.
In this study a new standardized technique for augmentation of screw tips using high viscous PMMA cement (Traumacem V+) with the PHILOS plate will be applied. Fracture treatment with PHILOS Screw Augmentation will be compared with treatment with PHILOS without augmentation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: PHILOS + Proximal Humeral Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+). |
Device: PHILOS+
Proximal Humerus Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).
Other Names:
|
| Active Comparator: PHILOS Proximal Humeral Internal Locking System (PHILOS) |
Device: PHILOS
Proximal Humerus Internal Locking System (PHILOS).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Any occurrence of radiographically confirmed mechanical failure during the first year after treatment. [one year]
Mechanical failures are defined as loss of reduction (≥ 15° increase of varus malposition between the immediate postoperative position and follow-up radiograph, relative change [5 mm] of greater or lesser tuberosity compared to the immediate postoperative position), head impaction (≥ 5 mm difference in outer plate edge and tangent of humeral head between immediate post-op and follow-up. The tangent is determined perpendicular to the humeral neck), screw/plate loosening (any change outwards of screw position in relation to immediate postoperative position) and secondary screw perforation (perforation of one or more screws through the humeral head into the joint space on the follow-up radiograph(and lack of screw perforation on the intra- or postoperative Rx based on a baseline anteroposterior and axial Rx.
Secondary Outcome Measures
- Patient reported outcome (Quality of life) [Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery]
EuroQol-5D (EQ-5D).
- Intra- and postoperative adverse events related to the procedure and/or device [Up to one year]
Implant/surgery , Bone/fracture, Soft tissue of the musculoskeletal system, Wound/other local tissue, Systemic/rest of the body.
- Reoperation rate [Up to one year]
- Surgical details [Intraoperative]
Surgery duration (skin to skin in min).
- Description of augmentation details [Intraoperative]
Number of screws augmented.
- Surgical details [Intraoperative]
Time of day of surgery.
- Surgical details [Intraoperative]
Number and position of screws used.
- Surgical details [Intra- /postoperative]
Anatomic/non-anatomic reduction.
- Surgical details [Intra- /postoperative]
Restoration of medial support.
- Description of augmentation details [Intraoperative]
Number of incidences of direct contrast fluid leakage.
- Description of augmentation details [Intraoperative]
Augmentation-related adverse events and their association with fracture characteristics.
- Description of augmentation details [Intraoperative]
Volume of injected cement (in ml).
- Shoulder function [Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery]
Shoulder Pain and Disability Index (SPADI).
- Shoulder function [Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery]
Constant score.
- Shoulder function [Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery]
Disabilities of the Arm, Shoulder and Hand Score (QuickDASH).
- Relation of patient factors on mechanical failures [Up to one year]
Comorbidity.
- Relation of patient factors on mechanical failures [Up to one year]
Mental health with Mini Mental State Examination (MMSE).
- Relation of patient factors on mechanical failures [Up to one year]
Bone mineral density (BMD) measured with CT.
- Relation of fracture characteristics on mechanical failures [Up to one year]
Number of fracture parts.
- Relation of fracture characteristics on mechanical failures [Up to one year]
Severity of displacement.
- Relation of fracture characteristics on mechanical failures [Up to one year]
Varus/valgus.
- Relation of surgical factors on mechanical failures [Up to one year]
Anatomic/non-anatomic reduction (varus, anteversion etc.).
- Relation of surgical factors on mechanical failures [Up to one year]
Restoration of medial support.
- Relation of surgical factors on mechanical failures [Up to one year]
Time of surgery.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 65 years
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Low energy trauma (e.g. fall from standing height)
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Radiologically confirmed closed fracture (≤ 10 days) of the proximal humerus
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Any displaced or unstable 3- or 4-part fracture of the proximal humerus (i.e. segment dis-placement > 0.5 cm or angulated > 45°) except isolated displaced fractures of the greater or lesser tuberosity
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Primary fracture treatment with a PHILOS plate
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Ability to understand the content of the patient information / informed consent form
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Willingness and ability to participate in the clinical investigation including imaging and fol-low-up procedures
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Signed informed consent
Preoperative Exclusion Criteria:
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Bilateral or previous proximal humerus fractures on either side
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Splitting fracture of the humeral head or humeral head impression fracture
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Cuff-arthropathy of the contra- or ipsilateral proximal humerus
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Associated nerve or vessel injury
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Any known clotting disorders, severe cardiac and/or pulmonary insufficiency
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Known hypersensitivity or allergy to any of the components of Traumacem V+ Cement Kit
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Any severe systemic disease: class 4 - 6 of the American Society of Anesthesiologists (ASA) physical status classification
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Any not medically managed severe systemic disease: class 3 of the ASA physical status classification
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Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
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Prisoner
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Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Intraoperative Exclusion Criteria:
- Intraoperative decision to use implants other than PHILOS/PHILOS Screw Augmentation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Innsbruck | Innsbruck | Austria | 6020 | |
| 2 | UZ Leuven | Leuven | Belgium | 3000 | |
| 3 | University Hospital RWTH Aachen | Aachen | Germany | 52074 | |
| 4 | University Medical Center Freiburg | Freiburg | Germany | 79095 | |
| 5 | Saarland University Medical Center | Homburg | Germany | 66421 | |
| 6 | BG Clinic Ludwigshafen | Ludwigshafen | Germany | 67071 | |
| 7 | BG Clinic Tübingen | Tübingen | Germany | 72076 | |
| 8 | Cantonal Hospital Lucerne | Lucerne | Switzerland | 6000 | |
| 9 | Triemli hospital | Zürich | Switzerland | 8063 |
Sponsors and Collaborators
- AO Clinical Investigation and Publishing Documentation
Investigators
- Study Director: Andreas Faeh, AO Clinical Investigation and Documentation, Davos, Switzerland
- Principal Investigator: Franz Kralinger, PD, MD, Medical University of Innsbruck, Austria
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- PHILOS+