Osteoporotic proximal humeral fracture (OPHF)
Conditions
Interventions
Group B:Internal fixation using the novel bio-enhanced plate system.
Group A :Traditional locking steel plate PHILOS steel plate system is used for internal fixation.
Group C:Internal fixation with the novel bio-enhanced system combined with injectable calcium phosphate artificial bone.
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 60-85 years; 2. Diagnosed with an acute, closed Neer three- or four-part proximal humeral fracture by X-ray and CT scan; 3. A bone mineral density T-score of <= -2.5 SD as measured by dual-energy X-ray absorptiometry (DXA), or a T-score of <= -2.0 SD in the presence of a history of fragility fracture; 4. Time from injury to scheduled surgery <= 2 weeks; 5. Voluntarily participate in the study and provide signed informed consent;
Exclusion criteria
Exclusion criteria: 1. Pathological fractures or concomitant severe fractures at other sites. 2. Previous surgical history, deformity, or dysfunction in the affected shoulder joint. 3. Associated injuries to the axillary nerve or brachial plexus. 4. Severe cardiac, cerebral, pulmonary, hepatic, or renal insufficiency, rendering the patient unable to tolerate surgery. 5. Allergy to artificial bone materials or internal fixation implants. 6. Concomitant neurological disorders affecting bone metabolism or functional outcomes (e.g., rheumatoid arthritis, Parkinson's disease). 7. Long-term use of corticosteroids or immunosuppressants. 8. Cognitive impairment, unable to cooperate with follow-up and rehabilitation. 9. Expected survival of less than 1 year. 10. Concurrent participation in other clinical trials that may interfere with the results of this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Disability Score;Safety Assessment;Imaging Assessment ;Visual Analog Scale (VAS); | — |
Primary
| Measure | Time frame |
|---|---|
| Constant-Murley Score; | — |
Countries
China
Contacts
Public ContactSu Jiacan
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed