PHILOS Screw Augmentation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AO Clinical Investigation and Documentation
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01847508
First received: April 26, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Humerus Fractures
Closed Fracture of the Proximal Humerus
Device: PHILOS+
Device: PHILOS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Any occurrence of radiographically confirmed mechanical failure during the first year after treatment. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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:
  • Quality of life [ Time Frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery ] [ Designated as safety issue: No ]
    EuroQol-5D (EQ-5D).

  • Intra- and postoperative adverse events related to the procedure and/or device [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Implant/surgery , Bone/fracture, Soft tissue of the musculoskeletal system, Wound/other local tissue, Systemic/rest of the body.

  • Reoperation rate [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Surgical details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Surgery duration (skin to skin in min).

  • Description of augmentation details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Number of screws augmented.

  • Surgical details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Time of day of surgery.

  • Surgical details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Number and position of screws used.

  • Surgical details [ Time Frame: Intra- /postoperative ] [ Designated as safety issue: No ]
    Anatomic/non-anatomic reduction.

  • Surgical details [ Time Frame: Intra- /postoperative ] [ Designated as safety issue: No ]
    Restoration of medial support.

  • Description of augmentation details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Number of incidences of direct contrast fluid leakage.

  • Description of augmentation details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Augmentation-related adverse events and their association with fracture characteristics.

  • Description of augmentation details [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Volume of injected cement (in ml).

  • Shoulder function [ Time Frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery ] [ Designated as safety issue: No ]
    Shoulder Pain and Disability Index (SPADI).

  • Shoulder function [ Time Frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery ] [ Designated as safety issue: No ]
    Constant score.

  • Shoulder function [ Time Frame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery ] [ Designated as safety issue: No ]
    Disabilities of the Arm, Shoulder and Hand Score (QuickDASH).

  • Relation of patient factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Comorbidity.

  • Relation of patient factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Mental health with Mini Mental State Examination (MMSE).

  • Relation of patient factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Bone mineral density (BMD) measured with CT.

  • Relation of fracture characteristics on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Number of fracture parts.

  • Relation of fracture characteristics on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Severity of displacement.

  • Relation of fracture characteristics on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Varus/valgus.

  • Relation of surgical factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Anatomic/non-anatomic reduction (varus, anteversion etc.).

  • Relation of surgical factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Restoration of medial support.

  • Relation of surgical factors on mechanical failures [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
    Time of surgery.


Estimated Enrollment: 128
Study Start Date: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847508

Contacts
Contact: Jan Ljungqvist +41 44 200 24 61 jan.ljungqvist@aofoundation.org

Locations
Austria
Medical University of Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: Franz Kralinger, MD         
Principal Investigator: Franz Kralinger, PD, MD         
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Stefaan Nijs, M.D.         
Principal Investigator: Stefaan Nijs, MD         
Germany
University Hospital RWTH Aachen Not yet recruiting
Aachen, Germany, 52074
Contact: Gertraud Gradl, MD         
Principal Investigator: Gertraud Gradl, MD         
University Medical Center Freiburg Recruiting
Freiburg, Germany, 79095
Contact: Norbert Südkamp, MD         
Principal Investigator: Norbert Südkamp, MD         
Sub-Investigator: Martin Jaeger, MD         
Saarland University Medical Center Not yet recruiting
Homburg, Germany, 66421
Contact: Tim Pohlemann, MD         
Principal Investigator: Tim Pohlemann, MD         
Sub-Investigator: Jörg Holstein, PD, MD         
BG Clinic Ludwigshafen Not yet recruiting
Ludwigshafen, Germany, 67071
Contact: Jochen Franke, MD         
Principal Investigator: Jochen Franke, MD         
Sub-Investigator: Marc Schoen, MD         
Sub-Investigator: Daniel Matte, MD         
Sub-Investigator: Philipp von der Linden, MD         
BG Clinic Tübingen Not yet recruiting
Tübingen, Germany, 72076
Contact: Christian Bahrs, MD         
Principal Investigator: Christian Bahrs, MD         
Switzerland
Cantonal Hospital Lucerne Not yet recruiting
Lucerne, Switzerland, 6000
Contact: Reto Babst, MD         
Principal Investigator: Reto Babst, MD         
Sub-Investigator: Alexander Brunner, PD, MD         
Triemli hospital Recruiting
Zürich, Switzerland, 8063
Contact: Andreas Platz, MD         
Principal Investigator: Andreas Platz, MD         
Sub-Investigator: Mario Rancan, MD         
Sub-Investigator: Ünal Can, MD         
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Study Director: Beate P. Hanson, MD AO Clinical Investigation and Documentation, Davos, Switzerland
Principal Investigator: Franz Kralinger, PD, MD Medical University of Innsbruck, Austria
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01847508     History of Changes
Other Study ID Numbers: PHILOS+
Study First Received: April 26, 2013
Last Updated: July 24, 2014
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
Germany: Ethics Commission
Switzerland: Ethikkommission

Additional relevant MeSH terms:
Arm Injuries
Fractures, Bone
Fractures, Closed
Humeral Fractures
Wounds and Injuries
Polymethyl Methacrylate
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014