Humeral FractureDELTOSUPEXNCT03694457
Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture
A study testing Reversed total shoulder arthroplasty and lateral approach in people with Humeral Fracture and Aged Patient, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Humeral Fracture, Aged Patient, Reversed Total Shoulder Arthroplasty
- What is being tested?
- Reversed total shoulder arthroplasty and lateral approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2018to 30 Jun 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient older than 65yo with a proximal humerus fracture (Neer 3-4 and 2 dislcated)
- Patient registered to the national health system
- Patient able to understand information about the protocol and answer to questionnaire
Who cannot join
- Non-displaced fracture or no need of surgical treatment.
- Existing bone disease
- Infection
- Neurological deficit (axillary nerve)
- Multi-injured patients
- Patient no able to fulfill the questionnaire
- Patient refuses the study
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.
Read the detailed description
The 2 main surgical approaches in total shoulder arthroplasty (TSA) are the anterior approach (deltopectoral) and the lateral one (deltoid splitting) (18).
Their advantages and drawbacks have not been clearly evaluated in proximal humerus fracture treated with an arthroplasty.
The goal of the study is to compare the results between patients (older than 65yo) presenting a proximal humerus fracture treated with a reversed shoulder arthroplasty performed through an anterior approach or a lateral one.
- Being tested
- Reversed total shoulder arthroplasty, lateral approach
- Keywords
- Prospective, Randomized study, Proximal humerus fracture, Surgical treatment
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reversed total shoulder arthroplastyProcedure or surgery
Replacement of the proximal humeral head by a reversed prosthesis through an anterior approach
lateral approachProcedure or surgery
Replacement of the proximal humeral head by a reversed prosthesis through a lateral approach
| Study group | Role | What they receive |
|---|---|---|
| deltopectoral approach | Active comparator | the patients are treated with deltopectoral approach surgery Receives: Procedure: Reversed total shoulder arthroplasty |
| lateral approach | Other | the patients are treated with a lateral approach surgery Receives: Procedure: lateral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Murley Score
Constant Murley Score it a clinical method of functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
Measured: 12 months
Secondary outcomes (8)
Quick dash score
the Quick Dash score is a functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
Measured: 3, 6 and 12 months
SF12 score
The SF12 score is a quality of life assessment. The score varies between 0 and 100, more the value is better brought up is the score
Measured: 3, 6 and 12 months
Alder score
Assessment of external rotation of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
Measured: 3, 6 and 12 months
The Simple Shoulder Test (SST)
The Simple Shoulder Test is functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
Measured: 3, 6 and 12 months
WOOS (The Western Ontario Osteosarthritis )
The Western Ontario Osteosarthritis of the shoulder index is a quality of life measurement tool for osteoarthritis of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
Measured: 3, 6 and 12 months
intensity of pain
THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)
Measured: pre op, 3, 6 and 12 months
Radiologic evaluation
Radiologic evaluation
Measured: pre op, 3, 6 and 12 months
Complications
list of the complications
Measured: pre op, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start26 Nov 2018
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
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 Humeral FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume VILLATTE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694457
- Sponsor's protocol ID
- CHU-410
- Other IDs
- 2018-A02113-52
- Acronym
- DELTOSUPEX
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2018
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture
- ClinicalTrials.gov ID
- NCT03694457
- Acronym / sponsor ID
- DELTOSUPEX / CHU-410
- Keywords
- Prospective, Randomized study, Proximal humerus fracture, Surgical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Oct 2018 (actual)
- 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.
The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.
Detailed description
The 2 main surgical approaches in total shoulder arthroplasty (TSA) are the anterior approach (deltopectoral) and the lateral one (deltoid splitting) (18).
Their advantages and drawbacks have not been clearly evaluated in proximal humerus fracture treated with an arthroplasty.
The goal of the study is to compare the results between patients (older than 65yo) presenting a proximal humerus fracture treated with a reversed shoulder arthroplasty performed through an anterior approach or a lateral one.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deltopectoral approach | Active comparator | Procedure: Reversed total shoulder arthroplastythe patients are treated with deltopectoral approach surgery |
| lateral approach | Other | Procedure: lateral approachthe patients are treated with a lateral approach surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patient older than 65yo with a proximal humerus fracture (Neer 3-4 and 2 dislcated)
- Patient registered to the national health system
- Patient able to understand information about the protocol and answer to questionnaire
Key exclusion criteria (7 listed)
- Non-displaced fracture or no need of surgical treatment.
- Existing bone disease
- Infection
- Neurological deficit (axillary nerve)
- Multi-injured patients
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 |
|---|---|---|
| Reversed total shoulder arthroplastyReplacement of the proximal humeral head by a reversed prosthesis through an anterior approach | Procedure or surgery | deltopectoral approach |
| lateral approachReplacement of the proximal humeral head by a reversed prosthesis through a lateral approach | Procedure or surgery | lateral approach |
Primary outcome
Constant Murley Score
Time frame: 12 months
Constant Murley Score it a clinical method of functional assessment of the shoulder. The score varies between 0 and 100, more the value is better brought up is the score
8 secondary outcomes
Quick dash score
Time frame: 3, 6 and 12 months
SF12 score
Time frame: 3, 6 and 12 months
Alder score
Time frame: 3, 6 and 12 months
The Simple Shoulder Test (SST)
Time frame: 3, 6 and 12 months
WOOS (The Western Ontario Osteosarthritis )
Time frame: 3, 6 and 12 months
intensity of pain
Time frame: pre op, 3, 6 and 12 months
Radiologic evaluation
Time frame: pre op, 3, 6 and 12 months
Complications
Time frame: pre op, 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- 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.
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Study on Outcomes of Proximal Humerus Fractures
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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.
Guillaume VILLATTE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reversed total shoulder arthroplasty and lateral approach in people with Humeral Fracture and Aged Patient, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 30 Dec 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Murley Score (time frame: 12 months). 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 NCT03694457, 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 30 Dec 2025.