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PHILOS Augmented - a Multicenter Randomized Controlled Trial

Primary Purpose

Humerus Fractures, Closed Fracture of the Proximal Humerus

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PHILOS+
PHILOS
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humerus Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Innsbruck
  • UZ Leuven
  • University Hospital RWTH Aachen
  • University Medical Center Freiburg
  • Saarland University Medical Center
  • BG Clinic Ludwigshafen
  • BG Clinic Tübingen
  • Cantonal Hospital Lucerne
  • Triemli hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PHILOS +

PHILOS

Arm Description

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

Proximal Humeral Internal Locking System (PHILOS)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient reported outcome (Quality of life)
EuroQol-5D (EQ-5D).
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.
Reoperation rate
Surgical details
Surgery duration (skin to skin in min).
Description of augmentation details
Number of screws augmented.
Surgical details
Time of day of surgery.
Surgical details
Number and position of screws used.
Surgical details
Anatomic/non-anatomic reduction.
Surgical details
Restoration of medial support.
Description of augmentation details
Number of incidences of direct contrast fluid leakage.
Description of augmentation details
Augmentation-related adverse events and their association with fracture characteristics.
Description of augmentation details
Volume of injected cement (in ml).
Shoulder function
Shoulder Pain and Disability Index (SPADI).
Shoulder function
Constant score.
Shoulder function
Disabilities of the Arm, Shoulder and Hand Score (QuickDASH).
Relation of patient factors on mechanical failures
Comorbidity.
Relation of patient factors on mechanical failures
Mental health with Mini Mental State Examination (MMSE).
Relation of patient factors on mechanical failures
Bone mineral density (BMD) measured with CT.
Relation of fracture characteristics on mechanical failures
Number of fracture parts.
Relation of fracture characteristics on mechanical failures
Severity of displacement.
Relation of fracture characteristics on mechanical failures
Varus/valgus.
Relation of surgical factors on mechanical failures
Anatomic/non-anatomic reduction (varus, anteversion etc.).
Relation of surgical factors on mechanical failures
Restoration of medial support.
Relation of surgical factors on mechanical failures
Time of surgery.

Full Information

First Posted
April 26, 2013
Last Updated
August 11, 2020
Sponsor
AO Clinical Investigation and Publishing Documentation
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1. Study Identification

Unique Protocol Identification Number
NCT01847508
Brief Title
PHILOS Augmented - a Multicenter Randomized Controlled Trial
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
November 3, 2017 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humerus Fractures, Closed Fracture of the Proximal Humerus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PHILOS +
Arm Type
Active Comparator
Arm Description
Proximal Humeral Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).
Arm Title
PHILOS
Arm Type
Active Comparator
Arm Description
Proximal Humeral Internal Locking System (PHILOS)
Intervention Type
Device
Intervention Name(s)
PHILOS+
Other Intervention Name(s)
PHILOS Length 90 mm with 3 shaft holes, PHILOS Length 114 mm with 5 shaft holes
Intervention Description
Proximal Humerus Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).
Intervention Type
Device
Intervention Name(s)
PHILOS
Other Intervention Name(s)
PHILOS Length 90 mm with 3 shaft holes, PHILOS Length 114 mm with 5 shaft holes
Intervention Description
Proximal Humerus Internal Locking System (PHILOS).
Primary Outcome Measure Information:
Title
Any occurrence of radiographically confirmed mechanical failure during the first year after treatment.
Description
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 Outcome Measure Information:
Title
Patient reported outcome (Quality of life)
Description
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
Title
Intra- and postoperative adverse events related to the procedure and/or device
Description
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
Title
Reoperation rate
Time Frame
Up to one year
Title
Surgical details
Description
Surgery duration (skin to skin in min).
Time Frame
Intraoperative
Title
Description of augmentation details
Description
Number of screws augmented.
Time Frame
Intraoperative
Title
Surgical details
Description
Time of day of surgery.
Time Frame
Intraoperative
Title
Surgical details
Description
Number and position of screws used.
Time Frame
Intraoperative
Title
Surgical details
Description
Anatomic/non-anatomic reduction.
Time Frame
Intra- /postoperative
Title
Surgical details
Description
Restoration of medial support.
Time Frame
Intra- /postoperative
Title
Description of augmentation details
Description
Number of incidences of direct contrast fluid leakage.
Time Frame
Intraoperative
Title
Description of augmentation details
Description
Augmentation-related adverse events and their association with fracture characteristics.
Time Frame
Intraoperative
Title
Description of augmentation details
Description
Volume of injected cement (in ml).
Time Frame
Intraoperative
Title
Shoulder function
Description
Shoulder Pain and Disability Index (SPADI).
Time Frame
Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Title
Shoulder function
Description
Constant score.
Time Frame
Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Title
Shoulder function
Description
Disabilities of the Arm, Shoulder and Hand Score (QuickDASH).
Time Frame
Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Title
Relation of patient factors on mechanical failures
Description
Comorbidity.
Time Frame
Up to one year
Title
Relation of patient factors on mechanical failures
Description
Mental health with Mini Mental State Examination (MMSE).
Time Frame
Up to one year
Title
Relation of patient factors on mechanical failures
Description
Bone mineral density (BMD) measured with CT.
Time Frame
Up to one year
Title
Relation of fracture characteristics on mechanical failures
Description
Number of fracture parts.
Time Frame
Up to one year
Title
Relation of fracture characteristics on mechanical failures
Description
Severity of displacement.
Time Frame
Up to one year
Title
Relation of fracture characteristics on mechanical failures
Description
Varus/valgus.
Time Frame
Up to one year
Title
Relation of surgical factors on mechanical failures
Description
Anatomic/non-anatomic reduction (varus, anteversion etc.).
Time Frame
Up to one year
Title
Relation of surgical factors on mechanical failures
Description
Restoration of medial support.
Time Frame
Up to one year
Title
Relation of surgical factors on mechanical failures
Description
Time of surgery.
Time Frame
Up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Faeh
Organizational Affiliation
AO Clinical Investigation and Documentation, Davos, Switzerland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Franz Kralinger, PD, MD
Organizational Affiliation
Medical University of Innsbruck, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Hospital RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
University Medical Center Freiburg
City
Freiburg
ZIP/Postal Code
79095
Country
Germany
Facility Name
Saarland University Medical Center
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
BG Clinic Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67071
Country
Germany
Facility Name
BG Clinic Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Cantonal Hospital Lucerne
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Triemli hospital
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30805708
Citation
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.
Results Reference
result
PubMed Identifier
35727196
Citation
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.
Results Reference
derived
Links:
URL
https://link.springer.com/article/10.1007%2Fs00402-019-03142-6
Description
Link to publication

Learn more about this trial

PHILOS Augmented - a Multicenter Randomized Controlled Trial

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