Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly
Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 16, 2016
CompletedFirst Posted
Study publicly available on registry
September 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedOctober 31, 2017
October 1, 2017
3.5 years
September 16, 2016
October 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Individual relative Constant-Murley score
Constant-Murley score relative to the unaffected shoulder
2 years
Secondary Outcomes (7)
American Shoulder and Elbow Surgeons Shoulder (ASES) score
2 years
Constant-Murley score
2 years
12-Item Short Form Health Survey (SF-12)
2 years
Visual analog scale (VAS) for pain
2 years
Complication and reoperation rate
2 years
- +2 more secondary outcomes
Study Arms (2)
Locking plate
EXPERIMENTALSurgical treatment with open reduction and osteosynthesis with locking plate
Conservative
ACTIVE COMPARATORConservative treatment with sling and rehabilitation
Interventions
Open reduction and osteosynthesis with locking plate
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo - Department of Orthopedics and Traumatology
São Paulo, 05403-010, Brazil
Related Publications (1)
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.
PMID: 35727196DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
September 16, 2016
First Posted
September 23, 2016
Study Start
January 1, 2016
Primary Completion
July 1, 2019
Study Completion
January 1, 2020
Last Updated
October 31, 2017
Record last verified: 2017-10