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Humerus FracturesNCT01847508

PHILOS Augmented - a Multicenter Randomized Controlled Trial

A study testing PHILOS+ and PHILOS in people with Humerus Fractures and Closed Fracture of the Proximal Humerus, run by AO Clinical Investigation and Publishing Documentation at 9 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective is to compare the mechanical failure risks in the first year after treatment. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
PHILOS+ and PHILOS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
9 sitesin 4 countries
Study dates
Oct 2013to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

Germany5 sites

  • University Hospital RWTH Aachen

    Aachen, 52074

  • University Medical Center Freiburg

    Freiburg im Breisgau, 79095

  • Saarland University Medical Center

    Homburg, 66421

  • BG Clinic Ludwigshafen

    Ludwigshafen, 67071

  • BG Clinic Tübingen

    Tübingen, 72076

Other trials in Germany

Switzerland2 sites

  • Cantonal Hospital Lucerne

    Lucerne, 6000

  • Triemli hospital

    Zurich, 8063

Other trials in Switzerland

Austria1 site

  • Medical University of Innsbruck

    Innsbruck, 6020

Other trials in Austria

Belgium1 site

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

About this study

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

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

Read the 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.

Being tested
PHILOS+, PHILOS
Medical subject headings
Humeral Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHILOS+Device

    Also called PHILOS Length 90 mm with 3 shaft holes, PHILOS Length 114 mm with 5 shaft holes

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

  • PHILOSDevice

    Also called PHILOS Length 90 mm with 3 shaft holes, PHILOS Length 114 mm with 5 shaft holes

    Proximal Humerus Internal Locking System (PHILOS).

Study groups in NCT01847508
Study groupRoleWhat they receive
PHILOS +Active comparatorProximal Humeral Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).
Receives: Device: PHILOS+
PHILOSActive comparatorProximal Humeral Internal Locking System (PHILOS)
Receives: Device: PHILOS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: one year

Secondary outcomes (24)

  1. Patient reported outcome (Quality of life)

    EuroQol-5D (EQ-5D).

    Measured: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery

  2. 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.

    Measured: Up to one year

  3. Reoperation rate

    Measured: Up to one year

  4. Surgical details

    Surgery duration (skin to skin in min).

    Measured: Intraoperative

  5. Description of augmentation details

    Number of screws augmented.

    Measured: Intraoperative

  6. Surgical details

    Time of day of surgery.

    Measured: Intraoperative

  7. Surgical details

    Number and position of screws used.

    Measured: Intraoperative

  8. Surgical details

    Anatomic/non-anatomic reduction.

    Measured: Intra- /postoperative

  9. Surgical details

    Restoration of medial support.

    Measured: Intra- /postoperative

  10. Description of augmentation details

    Number of incidences of direct contrast fluid leakage.

    Measured: Intraoperative

  11. Description of augmentation details

    Augmentation-related adverse events and their association with fracture characteristics.

    Measured: Intraoperative

  12. Description of augmentation details

    Volume of injected cement (in ml).

    Measured: Intraoperative

  13. Shoulder function

    Shoulder Pain and Disability Index (SPADI).

    Measured: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery

  14. Shoulder function

    Constant score.

    Measured: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery

  15. Shoulder function

    Disabilities of the Arm, Shoulder and Hand Score (QuickDASH).

    Measured: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery

  16. Relation of patient factors on mechanical failures

    Comorbidity.

    Measured: Up to one year

  17. Relation of patient factors on mechanical failures

    Mental health with Mini Mental State Examination (MMSE).

    Measured: Up to one year

  18. Relation of patient factors on mechanical failures

    Bone mineral density (BMD) measured with CT.

    Measured: Up to one year

  19. Relation of fracture characteristics on mechanical failures

    Number of fracture parts.

    Measured: Up to one year

  20. Relation of fracture characteristics on mechanical failures

    Severity of displacement.

    Measured: Up to one year

  21. Relation of fracture characteristics on mechanical failures

    Varus/valgus.

    Measured: Up to one year

  22. Relation of surgical factors on mechanical failures

    Anatomic/non-anatomic reduction (varus, anteversion etc.).

    Measured: Up to one year

  23. Relation of surgical factors on mechanical failures

    Restoration of medial support.

    Measured: Up to one year

  24. Relation of surgical factors on mechanical failures

    Time of surgery.

    Measured: Up to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2013 (estimated)
  2. Study startOct 2013
  3. Primary completion3 Nov 2017
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01847508
Sponsor's protocol ID
PHILOS+
Status last verified
Aug 2020
First submitted
26 Apr 2013
Last updated
13 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30805708

  • 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.

    PubMed 35727196

Questions about this trial

What is this clinical trial studying?

A study testing PHILOS+ and PHILOS in people with Humerus Fractures and Closed Fracture of the Proximal Humerus, run by AO Clinical Investigation and Publishing Documentation at 9 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany, Switzerland, Austria, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any occurrence of radiographically confirmed mechanical failure during the first year after treatment. (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01847508, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.

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