Trial reportArchives of orthopaedic and trauma surgery2019
Cement augmentation of the proximal humerus internal locking system in elderly patients: a multicenter randomized controlled trial.
Trial report in Archives of orthopaedic and trauma surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01847508 (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), which is not on this map. Cited by 31 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
31 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- The effects of augmentation choices for locking plate fixation in proximal humerus fracture osteosynthesis: a systematic review and meta-analysis.Journal of orthopaedics and traumatology : official journal of the Italian Society of Orthopaedics and Traumatology · 2025Pooled it
- Reverse total shoulder arthroplasty versus locked plate fixation for proximal humeral fractures in the elderly: a systematic review.PloS one · 2025Pooled it
- Cement augmentation for proximal humerus fractures: a meta-analysis of randomized trials and observational studies.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2024Pooled it
- Cement-augmented locked plate fixation proximal humerus fractures in elderly patient: a systematic review and meta-analysis.BMC musculoskeletal disorders · 2024Pooled it
- Quality of Life and Pain after Proximal Humeral Fractures in the Elderly: A Systematic Review.Medicina (Kaunas, Lithuania) · 2023Pooled it
- The fragility and reverse fragility indices of proximal humerus fracture randomized controlled trials: a systematic review.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2022Pooled it
- Interventions for treating proximal humeral fractures in adults.The Cochrane database of systematic reviews · 2022Pooled it
- Clinical validation of the DRoPH score: a preoperative tool for estimating reduction difficulty in proximal humerus fractures.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2026Article
- Hydroxyapatite/poly-L-lactide mesh tube versus β-tricalcium phosphate granules in locking plate fixation of proximal humeral fractures: a retrospective comparative study.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2026Article
- Osteoporotic Fractures of the Proximal Humerus: an In-Depth Review of Current Management Options.Current osteoporosis reports · 2025Review
- Randomized controlled trials investigating proximal humerus fractures lack consensus in inclusion criteria.JSES reviews, reports, and techniques · 2025Article
- Modified PHILOS system utilizing a single bone cement calcar screw achieves optimal fixation stability and promotes bone healing: a biomechanical study and corresponding case series.BMC musculoskeletal disorders · 2025Article
- Clinical and radiographic outcome of open reduction and internal fixation of 3- and 4-part proximal humerus fractures augmented with impaction bone grafting and a magnesium-based bone filler.JSES international · 2025Article
- Enhancing fixation stability in proximal humerus fractures: screw orientation optimization in PHILOS plates through finite element analysis and biomechanical testing.Scientific reports · 2024Article
- Locking Plate Fixation with Calcium Phosphate Bone Cement Augmentation for Elderly Proximal Humerus Fractures-A Single-Center Experience and Literature Review.Journal of clinical medicine · 2024Review
- Assessment of therapeutic clinical trials for proximal humeral fractures.Clinics in shoulder and elbow · 2024Review
- Plate Fixation of Proximal Humerus Fractures: How to Get It Right and Future Directions for Improvement.Current reviews in musculoskeletal medicine · 2023Review
- Treatment Reality of Proximal Humeral Fractures in the Elderly-Trending Variants of Locking Plate Fixation in Germany.Journal of clinical medicine · 2023Article
- Continuous Shoulder Activity Tracking after Open Reduction and Internal Fixation of Proximal Humerus Fractures.Bioengineering (Basel, Switzerland) · 2023Article
- Does the magnitude of injuries affect the outcome of proximal humerus fractures treated by locked plating (PHILOS)?European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
introductionCement augmentation of the proximal humerus internal locking system (PHILOS) screws might reduce complication rates in osteoporotic bones. This study compared the risk of mechanical failure during the first year after PHILOS™ treatment of proximal humerus fractures (PHF) without (control group) and with (augmented group) screw augmentation. Secondary objectives were to report shoulder functions, quality of life (QoL), adverse events (AEs), and reoperation rates. MATERIALS AND
methodsThis multicenter randomized trial enrolled patients aged ≥ 65 years with displaced/unstable PHF from eight European centers. Randomization was performed during surgery through sealed opaque envelopes. Mechanical failures were assessed by two independent reviewers via radiographs, shoulder function by Quick DASH, SPADI, and Constant Murley scores, and QoL by EQ-5D. Follow-ups were planned at postoperative 6 weeks, 3, 6, and 12 months.
resultsThe preliminary analysis of 6-week radiographs of the first 59 enrolled patients suggested a mechanical failure rate lower than expected and the difference between groups was too small to be detected by the planned sample size of 144. The trial was prematurely terminated after 67 patients had been enrolled: 34 (27 eligible) in the control group and 33 (29 eligible) in the augmented group. Follow-ups were performed as planned. Nine patients had mechanical failures and the failure rates (95% CI) were: augmented group, 16.1% (5.5; 33.7); control group, 14.8% (4.2; 33.7); the relative risk (95% CI) for the augmented group was 1.09 (0.32; 3.65) compared to the control group (p = 1.000). No statistically significant differences in shoulder function, QoL, and AEs were observed between study groups at 1 year. Nine patients (15.8%) underwent a revision.
conclusionsDue to premature termination, the study was underpowered. A larger study will be necessary to determine if cement augmentation lowers the risk of mechanical failure rate.
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