Clinical Trial: Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Sao Paulo

Current Primary Outcome: Individual relative Constant-Murley score [ Time Frame: 2 years ]

Constant-Murley score relative to the unaffected shoulder


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • American Shoulder and Elbow Surgeons Shoulder (ASES) score [ Time Frame: 2 years ]
    Subjective functional evaluation
  • Constant-Murley score [ Time Frame: 2 years ]
  • 12-Item Short Form Health Survey (SF-12) [ Time Frame: 2 years ]
    Quality of life evaluation
  • Visual analog scale (VAS) for pain [ Time Frame: 2 years ]
  • Complication and reoperation rate [ Time Frame: 2 years ]
  • Radiographic evaluation [ Time Frame: 2 years ]
    Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria
  • Rotator cuff ultrasound and magnetic resonance [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: September 16, 2016
Date Started: January 2016
Date Completion: January 2020
Last Updated: September 21, 2016
Last Verified: September 2016