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Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

Primary Purpose

Shoulder Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Osteosynthesis with locking plate
Sling
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Fractures

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Sao Paulo - Department of Orthopedics and TraumatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Locking plate

Conservative

Arm Description

Surgical treatment with open reduction and osteosynthesis with locking plate

Conservative treatment with sling and rehabilitation

Outcomes

Primary Outcome Measures

Individual relative Constant-Murley score
Constant-Murley score relative to the unaffected shoulder

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2016
Last Updated
October 29, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02913378
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Locking plate
Arm Type
Experimental
Arm Description
Surgical treatment with open reduction and osteosynthesis with locking plate
Arm Title
Conservative
Arm Type
Active Comparator
Arm Description
Conservative treatment with sling and rehabilitation
Intervention Type
Procedure
Intervention Name(s)
Osteosynthesis with locking plate
Intervention Description
Open reduction and osteosynthesis with locking plate
Intervention Type
Procedure
Intervention Name(s)
Sling
Intervention Description
Conservative treatment with sling and rehabilitation
Primary Outcome Measure Information:
Title
Individual relative Constant-Murley score
Description
Constant-Murley score relative to the unaffected shoulder
Time Frame
2 years
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons Shoulder (ASES) score
Description
Subjective functional evaluation
Time Frame
2 years
Title
Constant-Murley score
Time Frame
2 years
Title
12-Item Short Form Health Survey (SF-12)
Description
Quality of life evaluation
Time Frame
2 years
Title
Visual analog scale (VAS) for pain
Time Frame
2 years
Title
Complication and reoperation rate
Time Frame
2 years
Title
Radiographic evaluation
Description
Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria
Time Frame
2 years
Title
Rotator cuff ultrasound and magnetic resonance
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Sao Paulo - Department of Orthopedics and Traumatology
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro EC Gracitelli, PhD
Phone
+5511 983052345
Email
mgracitelli@gmail.com
First Name & Middle Initial & Last Name & Degree
Fernando B Andrade-Silva, PhD
Phone
+ 55 11 983729983
Email
fbrandao86@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Fernando B Andrade-Silva, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35727196
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.
Results Reference
derived

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Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

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