PHILOS Augmented - a Multicenter Randomized Controlled Trial

Study Overview
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Brief Summary
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The primary objective is to compare the mechanical failure risks in the first year after treatment.

Detailed Description
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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.

Official Title
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A Multicenter Randomized Controlled Trial to Investigate the Treatment Outcome of PHILOS Screw Augmentation Compared to PHILOS Without Augmentation in Older Adult Patients With Proximal Humerus Fractures

Conditions
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Humerus Fractures, Closed Fracture of the Proximal Humerus

Intervention / Treatment
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* Device: PHILOS+
* Device: PHILOS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 65 years Low energy trauma (e.g. fall from standing height) Radiologically confirmed closed fracture (≤ 10 days) of the proximal humerus 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 Primary fracture treatment with a PHILOS plate Ability to understand the content of the patient information / informed consent form Willingness and ability to participate in the clinical investigation including imaging and fol-low-up procedures Signed informed consent Preoperative Exclusion Criteria: Bilateral or previous proximal humerus fractures on either side Splitting fracture of the humeral head or humeral head impression fracture Cuff-arthropathy of the contra- or ipsilateral proximal humerus Associated nerve or vessel injury Any known clotting disorders, severe cardiac and/or pulmonary insufficiency Known hypersensitivity or allergy to any of the components of Traumacem V+ Cement Kit Any severe systemic disease: class 4 - 6 of the American Society of Anesthesiologists (ASA) physical status classification Any not medically managed severe systemic disease: class 3 of the ASA physical status classification Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment Prisoner 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PHILOS +<br>Proximal Humeral Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+). | Device: PHILOS+<br>* Proximal Humerus Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).<br>* Other names: PHILOS Length 114 mm with 5 shaft holes;|
| Active Comparator: PHILOS<br>Proximal Humeral Internal Locking System (PHILOS) | Device: PHILOS<br>* Proximal Humerus Internal Locking System (PHILOS).<br>* Other names: PHILOS Length 114 mm with 5 shaft holes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |