An interventional study of PHILOS+ and PHILOS in Humerus Fractures and Closed Fracture of the Proximal Humerus, sponsored by AO Clinical Investigation and Publishing Documentation. Completed at 9 sites in 4 countries. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by AO Clinical Investigation and Publishing Documentation · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
The primary objective is to compare the mechanical failure risks in the first year after treatment.
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.
106 studies on the registry are indexed under Humeral Fractures; 20 are open to participants now.
This study's enrollment of 69 is above the median of 56 across 64 interventional studies indexed under Humeral Fractures.
Browse Humeral Fractures studies →AO Clinical Investigation and Publishing Documentation is the lead sponsor of 50 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Preoperative Exclusion Criteria:
Intraoperative Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proximal Humeral Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).
Device: PHILOS+
Proximal Humeral Internal Locking System (PHILOS)
Device: PHILOS
Proximal Humerus Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).
Also known as: PHILOS Length 90 mm with 3 shaft holes, PHILOS Length 114 mm with 5 shaft holes
Proximal Humerus Internal Locking System (PHILOS).
Also known as: PHILOS Length 90 mm with 3 shaft holes, PHILOS Length 114 mm with 5 shaft holes
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.
Time frame: one year
Patient reported outcome (Quality of life)
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
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.
Time frame: Up to one year
Reoperation rate
Time frame: Up to one year
Surgical details
Surgery duration (skin to skin in min).
Time frame: Intraoperative
Description of augmentation details
Number of screws augmented.
Time frame: Intraoperative
Surgical details
Time of day of surgery.
Time frame: Intraoperative
Surgical details
Number and position of screws used.
Time frame: Intraoperative
Surgical details
Anatomic/non-anatomic reduction.
Time frame: Intra- /postoperative
Surgical details
Restoration of medial support.
Time frame: Intra- /postoperative
Description of augmentation details
Number of incidences of direct contrast fluid leakage.
Time frame: Intraoperative
Description of augmentation details
Augmentation-related adverse events and their association with fracture characteristics.
Time frame: Intraoperative
Description of augmentation details
Volume of injected cement (in ml).
Time frame: Intraoperative
Shoulder function
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
Shoulder function
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
Shoulder function
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
Relation of patient factors on mechanical failures
Comorbidity.
Time frame: Up to one year
Relation of patient factors on mechanical failures
Mental health with Mini Mental State Examination (MMSE).
Time frame: Up to one year
Relation of patient factors on mechanical failures
Bone mineral density (BMD) measured with CT.
Time frame: Up to one year
Relation of fracture characteristics on mechanical failures
Number of fracture parts.
Time frame: Up to one year
Relation of fracture characteristics on mechanical failures
Severity of displacement.
Time frame: Up to one year
Relation of fracture characteristics on mechanical failures
Varus/valgus.
Time frame: Up to one year
Relation of surgical factors on mechanical failures
Anatomic/non-anatomic reduction (varus, anteversion etc.).
Time frame: Up to one year
Relation of surgical factors on mechanical failures
Restoration of medial support.
Time frame: Up to one year
Relation of surgical factors on mechanical failures
Time of surgery.
Time frame: Up to one year
Ran from Oct 2013 to primary completion in Nov 2017, 49 months.
Of 26 interventional studies with no phase under Humeral Fractures, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 50. This study's 49 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AO Clinical Investigation and Publishing Documentation