Proximal humerus fractures (PHF) upper arm/shoulder fracture
Conditions
Interventions
This study compares two treatment methods: locking plate fixation (LCP) alone
and LCP fixation combined with a femoral allograft. The study is designed with
two groups of patients, with each group u
Sponsors
Tergooiziekenhuizen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients between 40-70 years of age; Presenting with acute (
Exclusion criteria
Exclusion criteria: Head-split fractures; Pathological fractures due to malignancy or metastases; Individuals diagnosed with dementia or residing in institutional care or other cognitive impairment; Terminal illness; Patients with convulsive disorders, collagen diseases, and any other condition that might affect the mobility of the shoulder joint; Active joint or systemic infection; History of prior surgery on the same shoulder; Previous fracture in the same shoulder; Psychiatric illness that precludes informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the CMS between patients treated with LCP fixation plus femoral allograft and those treated with LCP fixation alone at 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are: 1) Functional and clinical outcomes: Oxford Shoulder Score (OSS), Subjective Shoulder Value (SSV), Numeric Rating Scale (NRS) en de EQ-5DL. 2) Radiological outcomes: Humeral Head Height (HHH), Humeral Neck-Shaft Angle (HNSA), consolidation and secondary displacement of the humeral head. 3) Incidence of complications | — |
Countries
Netherlands
Outcome results
None listed