PHILOS Augmented - a Multicenter Randomized Controlled Trial

NCT01847508 | Completed DMC

• 1 other identifier: PHILOS+
• Study Type: interventional
• Target: 69
• Locations: 4 countries
• Sites: 9

Brief Summary

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

Conditions

Humerus Fractures; Closed Fracture of the Proximal Humerus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Patient reported outcome (Quality of life)

  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

  Up to one year

• Reoperation rate

  Up to one year

• Surgical details

  Intraoperative

• Description of augmentation details

  Intraoperative

Study Arms (2)

PHILOS +

ACTIVE COMPARATOR

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

Device: PHILOS+

PHILOS

ACTIVE COMPARATOR

Proximal Humeral Internal Locking System (PHILOS)

Device: PHILOS

Interventions

PHILOS DEVICE

Proximal Humerus Internal Locking System (PHILOS).

Also known as: PHILOS Length 90 mm with 3 shaft holes, PHILOS Length 114 mm with 5 shaft holes

PHILOS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (9)

Medical University of Innsbruck

Innsbruck, 6020, Austria

Location

UZ Leuven

Leuven, 3000, Belgium

Location

University Hospital RWTH Aachen

Aachen, 52074, Germany

Location

University Medical Center Freiburg

Freiburg im Breisgau, 79095, Germany

Location

Saarland University Medical Center

Homburg, 66421, Germany

Location

BG Clinic Ludwigshafen

Ludwigshafen, 67071, Germany

Location

BG Clinic Tübingen

Tübingen, 72076, Germany

Location

Cantonal Hospital Lucerne

Lucerne, 6000, Switzerland

Location

Triemli hospital

Zurich, 8063, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 30805708 RESULT

• 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.

  PMID: 35727196 DERIVED

Related Links

• Link to publication

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Andreas Faeh

  AO Clinical Investigation and Documentation, Davos, Switzerland

  STUDY DIRECTOR

• Franz Kralinger, PD, MD

  Medical University of Innsbruck, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 7, 2013
• Study Start: October 1, 2013
• Primary Completion: November 3, 2017
• Study Completion: July 1, 2018
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

AU (1); BE (1); CH (2); DE (5)