PHILOS Augmented - a Multicenter Randomized Controlled Trial

Humerus Fractures Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847508
• Other study ID #: PHILOS+
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: July 2018

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2018
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Closed Fracture of the Proximal Humerus
• Fractures, Bone
• Fractures, Closed
• Humeral Fractures
• Humerus Fractures

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
Belgium	UZ Leuven	Leuven
Germany	University Hospital RWTH Aachen	Aachen
Germany	University Medical Center Freiburg	Freiburg
Germany	Saarland University Medical Center	Homburg
Germany	BG Clinic Ludwigshafen	Ludwigshafen
Germany	BG Clinic Tübingen	Tübingen
Switzerland	Cantonal Hospital Lucerne	Lucerne
Switzerland	Triemli hospital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Switzerland, 

References & Publications (1)

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 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient reported outcome (Quality of life)	EuroQol-5D (EQ-5D).	Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Secondary	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.	Up to one year
Secondary	Reoperation rate		Up to one year
Secondary	Surgical details	Surgery duration (skin to skin in min).	Intraoperative
Secondary	Description of augmentation details	Number of screws augmented.	Intraoperative
Secondary	Surgical details	Time of day of surgery.	Intraoperative
Secondary	Surgical details	Number and position of screws used.	Intraoperative
Secondary	Surgical details	Anatomic/non-anatomic reduction.	Intra- /postoperative
Secondary	Surgical details	Restoration of medial support.	Intra- /postoperative
Secondary	Description of augmentation details	Number of incidences of direct contrast fluid leakage.	Intraoperative
Secondary	Description of augmentation details	Augmentation-related adverse events and their association with fracture characteristics.	Intraoperative
Secondary	Description of augmentation details	Volume of injected cement (in ml).	Intraoperative
Secondary	Shoulder function	Shoulder Pain and Disability Index (SPADI).	Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Secondary	Shoulder function	Constant score.	Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Secondary	Shoulder function	Disabilities of the Arm, Shoulder and Hand Score (QuickDASH).	Preoperative, 6 weeks ±7 days, 12 weeks ± 14 days, 6 months ± 30 days, 12 months up to 425 days after surgery
Secondary	Relation of patient factors on mechanical failures	Comorbidity.	Up to one year
Secondary	Relation of patient factors on mechanical failures	Mental health with Mini Mental State Examination (MMSE).	Up to one year
Secondary	Relation of patient factors on mechanical failures	Bone mineral density (BMD) measured with CT.	Up to one year
Secondary	Relation of fracture characteristics on mechanical failures	Number of fracture parts.	Up to one year
Secondary	Relation of fracture characteristics on mechanical failures	Severity of displacement.	Up to one year
Secondary	Relation of fracture characteristics on mechanical failures	Varus/valgus.	Up to one year
Secondary	Relation of surgical factors on mechanical failures	Anatomic/non-anatomic reduction (varus, anteversion etc.).	Up to one year
Secondary	Relation of surgical factors on mechanical failures	Restoration of medial support.	Up to one year
Secondary	Relation of surgical factors on mechanical failures	Time of surgery.	Up to one year

External Links

•   Link to publication