Humeral Fracture, ProximalNCT03383991
Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures
A study testing Reverse Total Shoulder Arthroplasty and Hemiarthroplasty in people with Humeral Fracture, Proximal, run by Karolinska Institutet.
Trial summary
Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Humeral Fracture, Proximal
- What is being tested?
- Reverse Total Shoulder Arthroplasty and Hemiarthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- 10 Sep 2013to 2 Sep 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Displaced 3- or 4-part fracture of the proximal humerus
- Age over 70 years
- Independent living
- Low energy trauma
Who cannot join
- Pre-existing shoulder disease
- Severe cognitive dysfunction
- More than 14 days from injury to surgery
- Comorbidity that affects shoulder rehabilitation considerably
- Concurrent injury that affect shoulder rehabilitation considerably
About this study
Official title: Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures in Patients Older Than 70 Years. A Multicenter Randomized Controlled Trial
Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. The treatment of displaced fractures is more controversial. Consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. The use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty.
The aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.
- Conditions
- Humeral Fracture, Proximal
- Being tested
- Reverse Total Shoulder Arthroplasty, Hemiarthroplasty
- Keywords
- Humeral Fracture, Proximal, Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty, Shoulder Hemiarthroplasty
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Total Shoulder ArthroplastyProcedure or surgery
HemiarthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Reverse Total Shoulder Arthroplasty | Experimental | Not described Receives: Procedure: Reverse Total Shoulder Arthroplasty |
| Hemiarthroplasty | Active comparator | Not described Receives: Procedure: Hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley Score
The Constant-Murley score is used to assess shoulder function. The maximum score is 100 points. Higher scores represent better shoulder function.
Measured: 24 months
WOOS (Western Ontario Osteoarthritis of the Shoulder) Index
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start10 Sep 2013
- Primary completion2 Sep 2020
- Study completion2 Sep 2020
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 Fracture, ProximalStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Olerud, Karolinska Institutet
- Investigators
- Per Olerud, MD, Principal investigator, Karolinska InstitutetCarl Ekholm, MD, Study director, Sahlgrenska Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383991
- Sponsor's protocol ID
- 2013/1053-31/3
- Status last verified
- Sep 2020
- First submitted
- 14 Dec 2017
- Last updated
- 2 Sep 2020
- Results posted
- 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 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures in Patients Older Than 70 Years. A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03383991
- Acronym / sponsor ID
- 2013/1053-31/3
- Conditions
- Humeral Fracture, Proximal
- Keywords
- Humeral Fracture, Proximal, Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty, Shoulder Hemiarthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Sep 2013 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 27 Dec 2017 (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.
Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced. The majority of these are reliably treated nonoperatively with an acceptable functional outcome. The treatment of displaced fractures is more controversial. Consensus is lacking as to when surgery is indicated or what type of procedure to choose if surgery is elected. Displaced 3- and 4-part fractures where internal fixation is deemed unreliable have been considered an indication for hemiarthroplasty. Hemiarthroplasty gives reasonable control of pain but the resulting shoulder function and range of motion is unpredictable. The use of reverse total shoulder arthroplasty is increasing and might result in a better range of motion then hemiarthroplasty.
The aim of this multicenter study is to test the hypothesis that reverse total shoulder arthroplasty gives better shoulder function than hemiarthroplasty for displaced 3- and 4-part proximal humeral fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reverse Total Shoulder Arthroplasty | Experimental | Procedure: Reverse Total Shoulder Arthroplasty |
| Hemiarthroplasty | Active comparator | Procedure: Hemiarthroplasty |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Displaced 3- or 4-part fracture of the proximal humerus
- Age over 70 years
- Independent living
- Low energy trauma
Key exclusion criteria (5 listed)
- Pre-existing shoulder disease
- Severe cognitive dysfunction
- More than 14 days from injury to surgery
- Comorbidity that affects shoulder rehabilitation considerably
- Concurrent injury that affect shoulder rehabilitation considerably
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 Total Shoulder Arthroplasty | Procedure or surgery | Reverse Total Shoulder Arthroplasty |
| Hemiarthroplasty | Procedure or surgery | Hemiarthroplasty |
Primary outcome
Constant-Murley Score
Time frame: 24 months
The Constant-Murley score is used to assess shoulder function. The maximum score is 100 points. Higher scores represent better shoulder function.
WOOS (Western Ontario Osteoarthritis of the Shoulder) Index
Time frame: 24 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 2 Sep 2020.
- 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.
Per Olerud, MD principal investigator
Karolinska Institutet
Carl Ekholm, MD study director
Sahlgrenska Academy
Questions about this trial
What is this clinical trial studying?
A study testing Reverse Total Shoulder Arthroplasty and Hemiarthroplasty in people with Humeral Fracture, Proximal, run by Karolinska Institutet.
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 4 inclusion and 5 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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: 24 months). The study lists 2 primary outcomes in all. 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 NCT03383991, 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 2 Sep 2020.