PHILOS Augmented - a Multicenter Randomized Controlled Trial

NCT ID: NCT01847508

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-07-31

Brief Summary

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

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.

Conditions

Humerus Fractures; Closed Fracture of the Proximal Humerus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PHILOS +

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

Group Type: ACTIVE_COMPARATOR

PHILOS+

Intervention Type: DEVICE

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

PHILOS

Proximal Humeral Internal Locking System (PHILOS)

Group Type: ACTIVE_COMPARATOR

PHILOS

Intervention Type: DEVICE

Proximal Humerus Internal Locking System (PHILOS).

Interventions

PHILOS+

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

Intervention Type: DEVICE

PHILOS

Proximal Humerus Internal Locking System (PHILOS).

Intervention Type: DEVICE

Other Intervention Names

PHILOS Length 90 mm with 3 shaft holes; PHILOS Length 114 mm with 5 shaft holes; PHILOS Length 90 mm with 3 shaft holes; PHILOS Length 114 mm with 5 shaft holes

Eligibility Criteria

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

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 decision to use implants other than PHILOS/PHILOS Screw Augmentation

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Faeh

Role: STUDY_DIRECTOR

AO Clinical Investigation and Documentation, Davos, Switzerland

Franz Kralinger, PD, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Innsbruck, Austria

Locations

Medical University of Innsbruck

Innsbruck, , Austria

UZ Leuven

Leuven, , Belgium

University Hospital RWTH Aachen

Aachen, , Germany

University Medical Center Freiburg

Freiburg im Breisgau, , Germany

Saarland University Medical Center

Homburg, , Germany

BG Clinic Ludwigshafen

Ludwigshafen, , Germany

BG Clinic Tübingen

Tübingen, , Germany

Cantonal Hospital Lucerne

Lucerne, , Switzerland

Triemli hospital

Zurich, , Switzerland

Countries

Austria; Belgium; Germany; Switzerland

References

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.

Reference Type: RESULT

PMID: 30805708 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35727196 (View on PubMed)

Related Links

https://link.springer.com/article/10.1007%2Fs00402-019-03142-6

Link to publication

Other Identifiers

PHILOS+

Identifier Type: -

Identifier Source: org_study_id