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The primary objective is to compare the mechanical failure risks in the first year after treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHILOS + | Active Comparator | Proximal Humeral Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+). |
|
| PHILOS | Active Comparator | Proximal Humeral Internal Locking System (PHILOS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHILOS+ | Device | Proximal Humerus Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Any occurrence of radiographically confirmed mechanical failure during the first year after treatment. | 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. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcome (Quality of life) | EuroQol-5D (EQ-5D). | Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery |
| Intra- and postoperative adverse events related to the procedure and/or device |
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Inclusion Criteria:
Preoperative Exclusion Criteria:
Intraoperative Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Faeh | AO Clinical Investigation and Documentation, Davos, Switzerland | Study Director |
| Franz Kralinger, PD, MD | Medical University of Innsbruck, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Innsbruck | 6020 | Austria | |||
| UZ Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30805708 | Result | Hengg C, Nijs S, Klopfer T, Jaeger M, Platz A, Pohlemann T, Babst R, Franke J, Kralinger F. Cement augmentation of the proximal humerus internal locking system in elderly patients: a multicenter randomized controlled trial. Arch Orthop Trauma Surg. 2019 Jul;139(7):927-942. doi: 10.1007/s00402-019-03142-6. Epub 2019 Feb 25. | |
| 35727196 |
| Label | URL |
|---|---|
| Link to publication | View source |
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| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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|
| PHILOS | Device | Proximal Humerus Internal Locking System (PHILOS). |
|
|
Implant/surgery , Bone/fracture, Soft tissue of the musculoskeletal system, Wound/other local tissue, Systemic/rest of the body. |
| Up to one year |
| Reoperation rate | Up to one year |
| Surgical details | Surgery duration (skin to skin in min). | Intraoperative |
| Description of augmentation details | Number of screws augmented. | Intraoperative |
| Surgical details | Time of day of surgery. | Intraoperative |
| Surgical details | Number and position of screws used. | Intraoperative |
| Surgical details | Anatomic/non-anatomic reduction. | Intra- /postoperative |
| Surgical details | Restoration of medial support. | Intra- /postoperative |
| Description of augmentation details | Number of incidences of direct contrast fluid leakage. | Intraoperative |
| Description of augmentation details | Augmentation-related adverse events and their association with fracture characteristics. | Intraoperative |
| Description of augmentation details | Volume of injected cement (in ml). | Intraoperative |
| Shoulder function | Shoulder Pain and Disability Index (SPADI). | Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery |
| Shoulder function | Constant score. | Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery |
| Shoulder function | Disabilities of the Arm, Shoulder and Hand Score (QuickDASH). | Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery |
| Relation of patient factors on mechanical failures | Comorbidity. | Up to one year |
| Relation of patient factors on mechanical failures | Mental health with Mini Mental State Examination (MMSE). | Up to one year |
| Relation of patient factors on mechanical failures | Bone mineral density (BMD) measured with CT. | Up to one year |
| Relation of fracture characteristics on mechanical failures | Number of fracture parts. | Up to one year |
| Relation of fracture characteristics on mechanical failures | Severity of displacement. | Up to one year |
| Relation of fracture characteristics on mechanical failures | Varus/valgus. | Up to one year |
| Relation of surgical factors on mechanical failures | Anatomic/non-anatomic reduction (varus, anteversion etc.). | Up to one year |
| Relation of surgical factors on mechanical failures | Restoration of medial support. | Up to one year |
| Relation of surgical factors on mechanical failures | Time of surgery. | Up to one year |
| Leuven |
| 3000 |
| Belgium |
| University Hospital RWTH Aachen | Aachen | 52074 | Germany |
| University Medical Center Freiburg | Freiburg im Breisgau | 79095 | Germany |
| Saarland University Medical Center | Homburg | 66421 | Germany |
| BG Clinic Ludwigshafen | Ludwigshafen | 67071 | Germany |
| BG Clinic Tübingen | Tübingen | 72076 | Germany |
| Cantonal Hospital Lucerne | Lucerne | 6000 | Switzerland |
| Triemli hospital | Zurich | 8063 | Switzerland |
| Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. |