Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02913378
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : October 31, 2017
Information provided by (Responsible Party):
Mauro Gracitelli, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Shoulder Fractures Procedure: Osteosynthesis with locking plate Procedure: Sling Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Locking plate
Surgical treatment with open reduction and osteosynthesis with locking plate
Procedure: Osteosynthesis with locking plate
Open reduction and osteosynthesis with locking plate

Active Comparator: Conservative
Conservative treatment with sling and rehabilitation
Procedure: Sling
Conservative treatment with sling and rehabilitation

Primary Outcome Measures :
  1. Individual relative Constant-Murley score [ Time Frame: 2 years ]
    Constant-Murley score relative to the unaffected shoulder

Secondary Outcome Measures :
  1. American Shoulder and Elbow Surgeons Shoulder (ASES) score [ Time Frame: 2 years ]
    Subjective functional evaluation

  2. Constant-Murley score [ Time Frame: 2 years ]
  3. 12-Item Short Form Health Survey (SF-12) [ Time Frame: 2 years ]
    Quality of life evaluation

  4. Visual analog scale (VAS) for pain [ Time Frame: 2 years ]
  5. Complication and reoperation rate [ Time Frame: 2 years ]
  6. Radiographic evaluation [ Time Frame: 2 years ]
    Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria

  7. Rotator cuff ultrasound and magnetic resonance [ Time Frame: 2 years ]

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02913378

University of Sao Paulo - Department of Orthopedics and Traumatology Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Mauro EC Gracitelli, PhD    +5511 983052345   
Contact: Fernando B Andrade-Silva, PhD    + 55 11 983729983   
Principal Investigator: Fernando B Andrade-Silva, MD         
Sponsors and Collaborators
University of Sao Paulo

Responsible Party: Mauro Gracitelli, PhD, University of Sao Paulo Identifier: NCT02913378     History of Changes
Other Study ID Numbers: ProxhumerusUSP
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries
Arm Injuries
Shoulder Injuries