Shoulder FracturesNCT02913378
Conservative vs Surgical Treatment for Proximal Humerus Fractures in the Elderly
A study testing Osteosynthesis with locking plate and Sling in people with Shoulder Fractures, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Shoulder Fractures
- What is being tested?
- Osteosynthesis with locking plate and Sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo - Department of Orthopedics and Traumatology
São Paulo, 05403-010
Mauro EC Gracitelli, PhD, +5511 983052345, mgracitelli@gmail.com
Fernando B Andrade-Silva, PhD, + 55 11 983729983, fbrandao86@yahoo.com.br
About this study
Official title: Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Shoulder Fractures
- Being tested
- Osteosynthesis with locking plate, Sling
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteosynthesis with locking plateProcedure or surgery
Open reduction and osteosynthesis with locking plate
SlingProcedure or surgery
Conservative treatment with sling and rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Locking plate | Experimental | Surgical treatment with open reduction and osteosynthesis with locking plate Receives: Procedure: Osteosynthesis with locking plate |
| Conservative | Active comparator | Conservative treatment with sling and rehabilitation Receives: Procedure: Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual relative Constant-Murley score
Constant-Murley score relative to the unaffected shoulder
Measured: 2 years
Secondary outcomes (7)
American Shoulder and Elbow Surgeons Shoulder (ASES) score
Subjective functional evaluation
Measured: 2 years
Constant-Murley score
Measured: 2 years
12-Item Short Form Health Survey (SF-12)
Quality of life evaluation
Measured: 2 years
Visual analog scale (VAS) for pain
Measured: 2 years
Complication and reoperation rate
Measured: 2 years
Radiographic evaluation
Union, head-shaft angle, tuberosities reduction, medial support and Fjalestad reduction criteria
Measured: 2 years
Rotator cuff ultrasound and magnetic resonance
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder FracturesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Gracitelli, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913378
- Sponsor's protocol ID
- ProxhumerusUSP
- Status last verified
- Oct 2017
- First submitted
- 16 Sep 2016
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35727196
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment vs Locked Plate Osteosynthesis for Proximal Humerus Fractures in the Elderly: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02913378
- Acronym / sponsor ID
- ProxhumerusUSP
- Conditions
- Shoulder Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locking plate | Experimental | Procedure: Osteosynthesis with locking plateSurgical treatment with open reduction and osteosynthesis with locking plate |
| Conservative | Active comparator | Procedure: SlingConservative treatment with sling and rehabilitation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- No contact between shaft and humeral head
- Head-shaft angle <100° on coronal plane
- Articular head fracture with displacement > 2mm
- Fracture-dislocation
- Bilateral fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteosynthesis with locking plateOpen reduction and osteosynthesis with locking plate | Procedure or surgery | Locking plate |
| SlingConservative treatment with sling and rehabilitation | Procedure or surgery | Conservative |
Primary outcome
Individual relative Constant-Murley score
Time frame: 2 years
Constant-Murley score relative to the unaffected shoulder
7 secondary outcomes
American Shoulder and Elbow Surgeons Shoulder (ASES) score
Time frame: 2 years
Constant-Murley score
Time frame: 2 years
12-Item Short Form Health Survey (SF-12)
Time frame: 2 years
Visual analog scale (VAS) for pain
Time frame: 2 years
Complication and reoperation rate
Time frame: 2 years
Radiographic evaluation
Time frame: 2 years
Rotator cuff ultrasound and magnetic resonance
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 35727196Handoll 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Sao Paulo - Department of Orthopedics and Traumatology
São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteosynthesis with locking plate and Sling in people with Shoulder Fractures, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual relative Constant-Murley score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.