Proximal humeral fractures
Conditions
Interventions
Cemented Reverse Total Shoulder Arthroplasty:Reverse shoulder arthroplasty with cement fixation
Cementless Reverse Total Shoulder Arthroplasty:Reverse total shoulder arthroplasty without cement fixation
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age 65–85 years (inclusive of 65 and 85 years); 2. Patients with unilateral proximal humeral fracture caused by trauma, confirmed by the attending physician on the basis of injury history, physical examination, X-rays and CT, and classified as Neer three-part or four-part fractures; 3. Patients for whom the multidisciplinary surgical team has determined that reverse total shoulder arthroplasty is indicated and who are medically fit to undergo surgery (American Society of Anesthesiologists [ASA] physical status classification <= III); 4. Patients presenting in the acute phase of the fracture (within 3 weeks of injury); 5. Patients who have been adequately informed about the study and have provided written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1. Patients with a humeral shaft medullary cavity diameter =15mm: =15mm exceeds the largest prosthesis size and can only be fixed with bone cement. 2. Patients who, after preoperative assessment, meet strong indications for bone cement implantation mainly include the following situations: (1) Severe osteoporosis (indicated by DTI index): preoperative X-ray/CT evaluation shows proximal humeral DTI index <1.4 (indicating severe osteoporosis); (2) Severe comminution of the epiphysis/metaphysis or complete loss of medial column support: imaging indicates significant epiphyseal comminution, medial column cannot be reconstructed or is completely lost; (3) Fractures involving the humeral shaft: fracture line involving the humeral shaft (including extension from metaphysis to shaft or combined humeral shaft fracture) prevents reliable press-fit fixation; (4) Medullary cavity deformation/anatomic abnormalities affecting biological stem fixation: prior fracture malunion, medullary cavity narrowing/twisting, abnormal medullary expansion or other structural abnormalities, making it difficult to achieve initial stability with a biological stem; 3. Patients with absolute contraindications for bone cement implantation: for example, allergy to bone cement, high-risk populations for bone cement implantation syndrome (severe cardiopulmonary disease); 4. Patients with fractures in other locations or other organ injuries; 5. Patients with axillary nerve injury on the affected side or deltoid muscle strength grade 4 or below; 6. Patients with contraindications for MRI (having a pacemaker, claustrophobia, etc.); 7. Gustilo-Anderson type III open fractures or open fractures with vascular and nerve injuries; 8. Suspected or confirmed pathological fractures based on MRI, such as those with tumors, osteomalacia, osteomyelitis, or simple bone cysts; 9. History of trauma or surgery in the same upper limb; 10. Patients with mental disorders or who do not understand Chinese and cannot comprehend or complete the questionnaire independently.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constant-Murley Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| QuickDASH Score;ASES Score;VAS pain Score;EQ5D Score;ROM of shoulder;Complications;Co-therapies;Humeral neck-shaft angle;Acromiohumeral distance; | — |
Countries
China
Contacts
Public ContactChen Yunfeng; Wang Qiuke
Shanghai Sixth People's Hospital
Outcome results
None listed