Clinical trial NCT02913378: Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly
Official title: Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Fractures
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Proximal humeral fractures, involving humeral head, with at least one of the following parameters:
* Head-shaft angle between 100-200° or \>175° on coronal plane;
* Shaft translation (on coronal or sagittal plane) \> 1cm;
* Tuberosity displacement \> 0,5cm;
* Head shaft angulation \>45° in axial or sagittal plane;
* Less then 30 days

Exclusion Criteria:

* No contact between shaft and humeral head
* Head-shaft angle \<100° on coronal plane
* Articular head fracture with displacement \> 2mm
* Fracture-dislocation
* Bilateral fracture
* Open fracture
* Ipsilateral or contralateral superior limb fracture
* Pathological fracture (tumors or bone disease, except for osteoporosis)
* Previous rotator cuff complete tear
* Previous infection
* Neurological injury
* Previous shoulder surgery
* Inability to answer subjective scores

Primary outcomes:
measure: Individual relative Constant-Murley score
timeFrame: 2 years
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Shoulder (ASES) score
timeFrame: 2 years
measure: Constant-Murley score
timeFrame: 2 years
measure: 12-Item Short Form Health Survey (SF-12)
timeFrame: 2 years
measure: Visual analog scale (VAS) for pain
timeFrame: 2 years
measure: Complication and reoperation rate
timeFrame: 2 years
measure: Radiographic evaluation
timeFrame: 2 years
measure: Rotator cuff ultrasound and magnetic resonance
timeFrame: 2 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo - Department of Orthopedics and Traumatology
Study officials:
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.