Clinical trial NCT01847508: 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
Overall status: COMPLETED
Phase: NA
Conditions: Humerus Fractures
Closed Fracture of the Proximal Humerus
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Any occurrence of radiographically confirmed mechanical failure during the first year after treatment.
timeFrame: one year
Secondary outcomes:
measure: Patient reported outcome (Quality of life)
timeFrame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
measure: Intra- and postoperative adverse events related to the procedure and/or device
timeFrame: Up to one year
measure: Reoperation rate
timeFrame: Up to one year
measure: Surgical details
timeFrame: Intraoperative
measure: Description of augmentation details
timeFrame: Intraoperative
measure: Surgical details
timeFrame: Intraoperative
measure: Surgical details
timeFrame: Intraoperative
measure: Surgical details
timeFrame: Intra- /postoperative
measure: Surgical details
timeFrame: Intra- /postoperative
measure: Description of augmentation details
timeFrame: Intraoperative
measure: Description of augmentation details
timeFrame: Intraoperative
measure: Description of augmentation details
timeFrame: Intraoperative
measure: Shoulder function
timeFrame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
measure: Shoulder function
timeFrame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
measure: Shoulder function
timeFrame: Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
measure: Relation of patient factors on mechanical failures
timeFrame: Up to one year
measure: Relation of patient factors on mechanical failures
timeFrame: Up to one year
measure: Relation of patient factors on mechanical failures
timeFrame: Up to one year
measure: Relation of fracture characteristics on mechanical failures
timeFrame: Up to one year
measure: Relation of fracture characteristics on mechanical failures
timeFrame: Up to one year
measure: Relation of fracture characteristics on mechanical failures
timeFrame: Up to one year
measure: Relation of surgical factors on mechanical failures
timeFrame: Up to one year
measure: Relation of surgical factors on mechanical failures
timeFrame: Up to one year
measure: Relation of surgical factors on mechanical failures
timeFrame: Up to one year
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Leuven
country: Belgium
facility: UZ Leuven
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
city: Homburg
country: Germany
facility: Saarland University Medical Center
city: Ludwigshafen
country: Germany
facility: BG Clinic Ludwigshafen
city: Tübingen
country: Germany
facility: BG Clinic Tübingen
city: Lucerne
country: Switzerland
facility: Cantonal Hospital Lucerne
city: Zürich
country: Switzerland
facility: Triemli hospital
Study officials:
affiliation: AO Clinical Investigation and Documentation, Davos, Switzerland
name: Andreas Faeh
role: STUDY_DIRECTOR
affiliation: Medical University of Innsbruck, Austria
name: Franz Kralinger, PD, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.