PHILOS Augmented - a Multicenter Randomized Controlled Trial

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

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

Study Overview

• Status: Completed
• Conditions: Humerus Fractures; Closed Fracture of the Proximal Humerus
• Intervention / Treatment: Device: PHILOS+; Device: PHILOS

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medical University of Innsbruck
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• Germany
  • Aachen, Germany, 52074
    • University Hospital RWTH Aachen
  • Freiburg, Germany, 79095
    • University Medical Center Freiburg
  • Homburg, Germany, 66421
    • Saarland University Medical Center
  • Ludwigshafen, Germany, 67071
    • BG Clinic Ludwigshafen
  • Tübingen, Germany, 72076
    • BG Clinic Tübingen
• Switzerland
  • Lucerne, Switzerland, 6000
    • Cantonal Hospital Lucerne
  • Zürich, Switzerland, 8063
    • Triemli Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: PHILOS Length 90 mm with 3 shaft holes; PHILOS Length 114 mm with 5 shaft holes
Active Comparator: PHILOS; Proximal Humeral Internal Locking System (PHILOS)	Device: PHILOS; Proximal Humerus Internal Locking System (PHILOS).; Other Names: PHILOS Length 90 mm with 3 shaft holes; PHILOS Length 114 mm with 5 shaft holes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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:CD000434. doi: 10.1002/14651858.CD000434.pub5. Review.
• 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.

Helpful Links

• Link to publication

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): November 3, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: April 26, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Fractures, Closed; Humeral Fractures
• Other Study ID Numbers: PHILOS+

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No