PHILOS Augmented - a Multicenter Randomized Controlled Trial

AO Clinical Investigation and Publishing Documentation69 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Humerus Fractures Closed Fracture of the Proximal Humerus

Interventions

PHILOS+DEVICE

Proximal Humerus Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).

PHILOSDEVICE

Proximal Humerus Internal Locking System (PHILOS).

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (9)

Medical University of Innsbruck

Innsbruck, Austria

UZ Leuven

Leuven, Belgium

University Hospital RWTH Aachen

Aachen, Germany

University Medical Center Freiburg

Freiburg im Breisgau, Germany

Outcomes

Primary Outcomes

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.

Time frame: one year

Secondary Outcomes

Patient reported outcome (Quality of life)

EuroQol-5D (EQ-5D).

Time frame: 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.

Time frame: Up to one year

Reoperation rate

Time frame: Up to one year

Surgical details

Surgery duration (skin to skin in min).

Time frame: Intraoperative

Description of augmentation details

Number of screws augmented.

Time frame: Intraoperative

Data from ClinicalTrials.gov

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