An interventional study of Osteosynthesis with locking plate and Sling in Shoulder Fractures, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2017-10-31.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
This is a randomized trial comparing conservative with surgical treatment (with open reduction and locking plate fixation) for proximal humeral fractures in patients aged more than 60 years.
Different methods have been used in the treatment of proximal humeral fractures. Usually, treatment choice depends on fracture displacement, patient age, osteoporosis, and other characteristics. Locking plate fixation has become the most widely used method among surgical techniques, while partial arthroplasty is reserved for older patients and comminuted articular fractures. Generally, nonsurgical treatment involves a brief period with sling immobilization and physiotherapy rehabilitation.
A recent multicenter study showed no difference between conservative and surgical treatments, including internal fixation with locking plates. Two other randomized studies showed mixed results, with no relevant clinical differences between the methods. No previous trial has evaluated the quality of reduction in surgically treated fractures and its relation to outcomes. Our study aims to compare both techniques with a detailed radiographic and tomographic evaluation, in elderly patients. We also aim to evaluate the influence of reduction and plate positioning on clinical outcomes. This is a single center trial, in which surgeries will be performed by only two experienced surgeons.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 58 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Surgical treatment with open reduction and osteosynthesis with locking plate
Procedure: Osteosynthesis with locking plate
Conservative treatment with sling and rehabilitation
Procedure: Sling
Open reduction and osteosynthesis with locking plate
Conservative treatment with sling and rehabilitation
Individual relative Constant-Murley score
Constant-Murley score relative to the unaffected shoulder
Time frame: 2 years
American Shoulder and Elbow Surgeons Shoulder (ASES) score
Subjective functional evaluation
Time frame: 2 years
Constant-Murley score
Time frame: 2 years
12-Item Short Form Health Survey (SF-12)
Quality of life evaluation
Time frame: 2 years
Visual analog scale (VAS) for pain
Time frame: 2 years
Complication and reoperation rate
Time frame: 2 years
Radiographic evaluation
Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria
Time frame: 2 years
Rotator cuff ultrasound and magnetic resonance
Time frame: 2 years
Plan to share: Undecided
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo