Humeral FracturesNCT03610113
Reverse Or Nothing For Complex Proximal Humeral Fractures
A study testing Reverse shoulder arthroplasty in people with Humeral Fractures, run by Consorci Sanitari de l'Anoia at 1 site in Spain.
Trial summary
Reverse shoulder prosthesis has recently emerged as an acute treatment for complex proximal humeral fractures. Promising functional results have been reported in observational papers. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Humeral Fractures
- What is being tested?
- Reverse shoulder arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to Aug 2023
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with mental conditions available for rehabilitation protocols
- Patients presenting a 3 or 4 part proximal humeral fracture
Who cannot join
- Extremely displaced fractures with no bony contact or less than 1 cm.
- Cognitive impairment (Pfeiffer test >3)
- Shoulder dislocations
- Unable to sign informed consent or unable to respond to questionnaires
- Trauma or previous surgery of the extremity
- Open or pathological fracture
Show all 9Show fewer
- Vascular or neurological injury associated
- Unable to collaborate with rehabilitation
- Patients with serious comorbidities that discourage surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reverse Shoulder Arthroplasty Versus Conservative Treatment For Complex Proximal Fractures in Elderly Patients
Reverse shoulder prosthesis has recently emerged as an acute treatment for complex proximal humeral fractures. Promising functional results have been reported in observational papers.
However, no clinical trials have yet been reported when comparing the conservative treatment to surgical treatment through the use of reverse shoulder arthroplasty.
Read the detailed description
Introduction The proximal humeral fractures are frequent in the investigator's environment. Among them, about 20% are considered as complex features. Conservative treatment has traditionally offered an extensive range of results. The reverse shoulder prosthesis as a treatment for acute fractures of the proximal humeral in the elderly population has changed the therapeutic approach of this acute pathology. However, high-level evidence-based studies are still not available, when comparing the conservative treatment with the treatment with reverse shoulder prosthesis.
Objective To compare the functional results and complications of elderly patients presenting acute complex fractures of the proximal humerus through two types of treatments; conservative treatment and treatment with reverse shoulder prosthesis.
Methodology A prospective, multicentre and randomized study comparing conservative treatment with the surgical treatment at two years followup by the use of functional shoulder assessment (Constant scale), complications and re-interventions associated with each treatment. The quality of life will also be analyzed through the SF-36 health questionnaire
Expected results The null hypothesis of the work is based on the appearance of non-significant differences between the two groups of the study (conservative vs. surgical treatment), concerning functional status, complications, and re-interventions
- Conditions
- Humeral Fractures
- Being tested
- Reverse shoulder arthroplasty
- Keywords
- Conservative treatment, Reverse shoulder arthroplasty, Proximal humeral fractures
- Medical subject headings
- Humeral Fractures, Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse shoulder arthroplastyDevice
Also called Shoulder prosthesis
The implantation of reverse shoulder prosthesis, and reattachment of greater and lesser tuberosities
| Study group | Role | What they receive |
|---|---|---|
| CONSERVATIVE TREATMENT | No intervention | Conservative treatment is conceived to the use of sling for three weeks, followed by rehabilitation protocol |
| REVERSE ARTHROPLASTY TREATMENT | Experimental | This group receives a surgical intervention by the use of reverse shoulder arthroplasty through deltopectoral approach and tuberosities reattachment.
It is followed by the same rehabilitation protocol than conservative treatment Receives: Device: Reverse shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, Mobility, Strenght and Daily Life Activities. (Functional Outcome)
Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury and it ranges from 0 to 100 points. The test is divided into four subscales: pain (0 to 15 points), activities of daily living (0 to 20 points), strength (0 to 25 points) and range of motion: forward elevation (0 to 10 points), external rotation (o to 10 points), abduction (0 to 10 points) and internal rotation of the shoulder (0 to 10 points). Then, those range of motion items allocate from 0 to 40 points to the global score.
The higher the score, the higher the quality of the function.
Measured: 1 year
Secondary outcomes (3)
Number of participants with treatment-related surgical reinterventions
Number of participants with treatment-related adverse events that require an additional surgical treatment after the randomization; such as debridement, implant replacement In the control group; reinterventions will be measured by the necessity to receive a treatment for fracture sequelae such as an implantation of a shoulder prosthesis or any other surgical intervention
Measured: 1 year
Number of participants with treatment-related shoulder joint infection
Acute infection will be defined as swelling, erythema, fever, purulent discharge or increasing level of biological parameters such as C-reactive protein (CRP), white blood cell count (WBC).
Only expected in experimental/intervention group
Measured: 1 year
Number of participants with treatment-related Implant dislocation
It is defined as the number of patients in experimental arm presenting a radiological disalignement between the humeral component (stem) and the glenoid component (glenosphere).
Only expected in experimental/intervention group
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startSep 2016
- Primary completionAug 2023
- Study completionAug 2023
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 FracturesStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Anoia
- Sponsor type
- University, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Parc de Salut Mar
- Responsible party
- Principal investigator, Joan Miquel, Consorci Sanitari de l'Anoia
- Investigators
- Carlos Torrens, PhD, Study director, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610113
- Sponsor's protocol ID
- AC12-045
- Status last verified
- Aug 2023
- First submitted
- 16 Jul 2018
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Shoulder Arthroplasty Versus Conservative Treatment For Complex Proximal Fractures in Elderly Patients
- ClinicalTrials.gov ID
- NCT03610113
- Acronym / sponsor ID
- AC12-045
- Conditions
- Humeral Fractures
- Keywords
- Conservative treatment, Reverse shoulder arthroplasty, Proximal humeral fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'AnoiaUniversity, hospital or other
- Collaborators
- Germans Trias i Pujol Hospital, Parc de Salut Mar
- Study start
- Sep 2016 (actual)
- Primary completion
- Aug 2023 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 1 Aug 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.
Reverse shoulder prosthesis has recently emerged as an acute treatment for complex proximal humeral fractures. Promising functional results have been reported in observational papers.
However, no clinical trials have yet been reported when comparing the conservative treatment to surgical treatment through the use of reverse shoulder arthroplasty.
Detailed description
Introduction The proximal humeral fractures are frequent in the investigator's environment. Among them, about 20% are considered as complex features. Conservative treatment has traditionally offered an extensive range of results. The reverse shoulder prosthesis as a treatment for acute fractures of the proximal humeral in the elderly population has changed the therapeutic approach of this acute pathology. However, high-level evidence-based studies are still not available, when comparing the conservative treatment with the treatment with reverse shoulder prosthesis.
Objective To compare the functional results and complications of elderly patients presenting acute complex fractures of the proximal humerus through two types of treatments; conservative treatment and treatment with reverse shoulder prosthesis.
Methodology A prospective, multicentre and randomized study comparing conservative treatment with the surgical treatment at two years followup by the use of functional shoulder assessment (Constant scale), complications and re-interventions associated with each treatment. The quality of life will also be analyzed through the SF-36 health questionnaire
Expected results The null hypothesis of the work is based on the appearance of non-significant differences between the two groups of the study (conservative vs. surgical treatment), concerning functional status, complications, and re-interventions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONSERVATIVE TREATMENT | No intervention | –Conservative treatment is conceived to the use of sling for three weeks, followed by rehabilitation protocol |
| REVERSE ARTHROPLASTY TREATMENT | Experimental | Device: Reverse shoulder arthroplastyThis group receives a surgical intervention by the use of reverse shoulder arthroplasty through deltopectoral approach and tuberosities reattachment. It is followed by the same rehabilitation protocol than conservative treatment |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients with mental conditions available for rehabilitation protocols
- Patients presenting a 3 or 4 part proximal humeral fracture
Key exclusion criteria (9 listed)
- Extremely displaced fractures with no bony contact or less than 1 cm.
- Cognitive impairment (Pfeiffer test >3)
- Shoulder dislocations
- Unable to sign informed consent or unable to respond to questionnaires
- Trauma or previous surgery of the extremity
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 |
|---|---|---|
| Reverse shoulder arthroplastyAlso: Shoulder prosthesisThe implantation of reverse shoulder prosthesis, and reattachment of greater and lesser tuberosities | Device | REVERSE ARTHROPLASTY TREATMENT |
Primary outcome
Pain, Mobility, Strenght and Daily Life Activities. (Functional Outcome)
Time frame: 1 year
Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury and it ranges from 0 to 100 points. The test is divided into four subscales: pain (0 to 15 points), activities of daily living (0 to 20 points), strength (0 to 25 points) and range of motion: forward elevation (0 to 10 points), external rotation (o to 10 points), abduction (0 to 10 points) and internal rotation of the shoulder (0 to 10 points). Then, those range of motion items allocate from 0 to 40 points to the global score. The higher the score, the higher the quality of the function.
3 secondary outcomes
Number of participants with treatment-related surgical reinterventions
Time frame: 1 year
Number of participants with treatment-related shoulder joint infection
Time frame: 1 year
Number of participants with treatment-related Implant dislocation
Time frame: 1 year
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 29 Aug 2023.
- 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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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.
Carlos Torrens, PhD study director
Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reverse shoulder arthroplasty in people with Humeral Fractures, run by Consorci Sanitari de l'Anoia at 1 site in Spain.
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 2 inclusion and 9 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 29 Aug 2023. 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 Spain. 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?
Pain, Mobility, Strenght and Daily Life Activities. (Functional Outcome) (time frame: 1 year). 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 NCT03610113, 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 29 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.