Closed Fracture Proximal Humerus, Four PartNCT02597972
Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures
A study testing Fracture repair and Fracture repair with joint replacement in people with Closed Fracture Proximal Humerus, Four Part, run by Mayo Clinic at 1 site in United States.
Trial summary
Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared to shoulder repair (open reduction and internal fixation, ORIF)? Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Closed Fracture Proximal Humerus, Four Part
- What is being tested?
- Fracture repair and Fracture repair with joint replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 17 Dec 2018
- 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
- Neer 3 and 4-part proximal humerus fractures.
- Age greater than and equal to 70 years old.
- Functional deltoid musculature (axillary nerve intact).
Who cannot join
- Less than 70 years old.
- Dementia or inability to provide adequate follow up.
- Associated injuries: injuries of ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3 &Amp; 4-Part Proximal Humerus Fractures: A Randomized Prospective Study
Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared to shoulder repair (open reduction and internal fixation, ORIF)?
Read the detailed description
The purpose of this study is to compare validated clinical and functional outcomes between patients who acutely present with 3 and 4-part proximal humerus fractures treated with either ORIF or RTSA.
- Being tested
- Fracture repair, Fracture repair with joint replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture repairProcedure or surgery
Fracture repair with joint replacementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Open Reduction Internal Fixation Proximal Humerus | Active comparator | The patients randomized into the ORIF group will receive standard surgical treatment of their proximal humerus fracture with a proximal humeral locking plate. Receives: Procedure: Fracture repair |
| Reverse Total Shoulder Arthroplasty | Active comparator | The patients randomized into the RTSA group will receive standard surgical treatment of their proximal humeral fracture with a Reverse Total Shoulder Arthroplasty. Receives: Procedure: Fracture repair with joint replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the change using the chi-square tests for lowering the pain score of the patients
threshold of statistical significance will be set at α = 0.05.
Measured: base line to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startSep 2015
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Why it stopped: project opened under new PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Fracture Proximal Humerus, Four PartStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquin Sanchez-Sotelo, M.D., Ph.D., Mayo Clinic
- Investigators
- Joaquin Sanchez-Sotelo, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597972
- Sponsor's protocol ID
- 15-004148
- Status last verified
- Jan 2020
- First submitted
- 17 Sep 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3 &Amp; 4-Part Proximal Humerus Fractures: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02597972
- Acronym / sponsor ID
- 15-004148
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: project opened under new PI
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 5 Nov 2015 (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.
Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared to shoulder repair (open reduction and internal fixation, ORIF)?
Detailed description
The purpose of this study is to compare validated clinical and functional outcomes between patients who acutely present with 3 and 4-part proximal humerus fractures treated with either ORIF or RTSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Reduction Internal Fixation Proximal Humerus | Active comparator | Procedure: Fracture repairThe patients randomized into the ORIF group will receive standard surgical treatment of their proximal humerus fracture with a proximal humeral locking plate. |
| Reverse Total Shoulder Arthroplasty | Active comparator | Procedure: Fracture repair with joint replacementThe patients randomized into the RTSA group will receive standard surgical treatment of their proximal humeral fracture with a Reverse Total Shoulder Arthroplasty. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Neer 3 and 4-part proximal humerus fractures.
- Age greater than and equal to 70 years old.
- Functional deltoid musculature (axillary nerve intact).
Key exclusion criteria (3 listed)
- Less than 70 years old.
- Dementia or inability to provide adequate follow up.
- Associated injuries: injuries of ipsilateral limb, complete brachial plexopathy, vascular injury and polytrauma.
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 |
|---|---|---|
| Fracture repair | Procedure or surgery | Open Reduction Internal Fixation Proximal Humerus |
| Fracture repair with joint replacement | Procedure or surgery | Reverse Total Shoulder Arthroplasty |
Primary outcome
To measure the change using the chi-square tests for lowering the pain score of the patients
Time frame: base line to 2 years
threshold of statistical significance will be set at α = 0.05.
Results and safety
The study was stopped early (reason given: project opened under new PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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.
Joaquin Sanchez-Sotelo, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fracture repair and Fracture repair with joint replacement in people with Closed Fracture Proximal Humerus, Four Part, run by Mayo Clinic at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 27 Jan 2020. 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 United States. 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 was stopped early (reason given: project opened under new PI). Results are not available in the source record.
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?
To measure the change using the chi-square tests for lowering the pain score of the patients (time frame: base line to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2020.