Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

Shoulder Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02913378
• Other study ID #: ProxhumerusUSP
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2016
• Last updated: October 29, 2017
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: October 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: January 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Shoulder Fractures

Intervention

Procedure:
• Osteosynthesis with locking plate
Open reduction and osteosynthesis with locking plate
• Sling
Conservative treatment with sling and rehabilitation

Locations

Country	Name	City	State
Brazil	University of Sao Paulo - Department of Orthopedics and Traumatology	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual relative Constant-Murley score	Constant-Murley score relative to the unaffected shoulder	2 years
Secondary	American Shoulder and Elbow Surgeons Shoulder (ASES) score	Subjective functional evaluation	2 years
Secondary	Constant-Murley score		2 years
Secondary	12-Item Short Form Health Survey (SF-12)	Quality of life evaluation	2 years
Secondary	Visual analog scale (VAS) for pain		2 years
Secondary	Complication and reoperation rate		2 years
Secondary	Radiographic evaluation	Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria	2 years
Secondary	Rotator cuff ultrasound and magnetic resonance		2 years