Humerus FractureNCT03599336
RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures
A study testing Reverse Total Shoulder Arthroplasty (rTSA) and Nonoperative Treatment in people with Humerus Fracture and Humerus, run by Mayo Clinic at 1 site in United States.
Trial summary
There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. No surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Humerus Fracture, Humerus, Shoulder Fractures
- What is being tested?
- Reverse Total Shoulder Arthroplasty (rTSA) and Nonoperative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 29 Oct 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Displaced 3- and 4-part proximal humerus fractures.
- Age greater than or equal to 65 years old.
Who cannot join
- Less than 65 years old.
- Medical comorbidities precluding surgical treatment or anesthesia
- Dementia or inability to provide adequate follow up.
- Pathologic fractures
- Open fractures
- Associated injuries: fracture dislocations, multiple or complex injuries of the 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 Nonoperative Treatment of 3 & 4-Part Proximal Humerus Fractures
There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. No surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. This study is being performed to evaluate the differences in short- and long-term pain and functional outcomes between patients who are treated with these two different options.
- Conditions
- Humerus Fracture, Humerus, Shoulder Fractures, Shoulder Arthropathy Associated With Other Conditions, Arthropathy Shoulder, Shoulder Injury
- Being tested
- Reverse Total Shoulder Arthroplasty (rTSA), Nonoperative Treatment
- Medical subject headings
- Humeral Fractures, Shoulder Fractures, Shoulder Injuries, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Total Shoulder Arthroplasty (rTSA)Procedure or surgery
Surgical management will include placement of fracture specific, cemented reverse total shoulder arthroplasty components as per standard surgical care and routine postoperative rehabilitation.
Nonoperative TreatmentOther
Subjects allocated to the nonoperative treatment arm will maintain sling immobilization for 3 weeks. The sling will be removed for elbow, wrist and hand range of motion (ROM), hygiene, and dressing only. At 3 weeks passive ROM in external rotation (ER) and forward elevation (FE) will be added. At 6 weeks from injury, the sling will be removed and stretching in all planes will be allowed. Use of the arm will be up to a fork/knife/toothbrush only. At 3 months from injury, strengthening will be added. Supervised physical therapy will be offered to patients for use at their discretion, as is current practice.
| Study group | Role | What they receive |
|---|---|---|
| Nonoperative Treatment | Other | Subjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts. Receives: Other: Nonoperative Treatment |
| Operative Course for rTSA | Other | Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts. Receives: Procedure: Reverse Total Shoulder Arthroplasty (rTSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function as described by ASES score at 1 year follow-up.
The American Shoulder and Elbow Surgeons (ASES) score is a well-validated, patient-reported outcome measure used by shoulder and elbow surgeons. The score ranges from 0-100 with 100 signifying the best outcome. Half of the score correlates to pain and half to function, both on a 0-50 scale where higher is again considered a better outcome. The pain portion is tabulated by taking the patient's response on a visual analogue scale (0 to 10 scale where 0 represent no pain and 10 represents worst pain imaginable), subtracting it from 10, and then multiplying by 5. The function score is tabulated by taking the patient's response on 10 questions rated on an ordinal scale from 0-3 and then multiplying the cumulative score by 5/3.
Measured: 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2018
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
Why it stopped: Slower than expected enrollment.
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 Humerus FractureStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan D. Barlow, Mayo Clinic
- Investigators
- Jonathan D Barlow, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599336
- Sponsor's protocol ID
- 18-002097
- Status last verified
- Oct 2021
- First submitted
- 30 Jun 2018
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- 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 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Total Shoulder Arthroplasty Versus Nonoperative Treatment of 3 & 4-Part Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT03599336
- Acronym / sponsor ID
- 18-002097
- Conditions
- Humerus Fracture, Humerus, Shoulder Fractures, Shoulder Arthropathy Associated With Other Conditions, Arthropathy Shoulder, Shoulder Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slower than expected enrollment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 26 Jul 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.
There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures. No surgery and surgery with a type of shoulder replacement called a reverse total shoulder arthroplasty are two options that many orthopedists use. This study is being performed to evaluate the differences in short- and long-term pain and functional outcomes between patients who are treated with these two different options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonoperative Treatment | Other | Other: Nonoperative TreatmentSubjects will have nonoperative treatment to treat proximal humerus fracture that is broken into 3 or 4 parts. |
| Operative Course for rTSA | Other | Procedure: Reverse Total Shoulder Arthroplasty (rTSA)Subjects will have shoulder replacement surgery to treat proximal humerus fracture that is broken into 3 or 4 parts. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Displaced 3- and 4-part proximal humerus fractures.
- Age greater than or equal to 65 years old.
Key exclusion criteria (6 listed)
- Less than 65 years old.
- Medical comorbidities precluding surgical treatment or anesthesia
- Dementia or inability to provide adequate follow up.
- Pathologic fractures
- Open fractures
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 (rTSA)Surgical management will include placement of fracture specific, cemented reverse total shoulder arthroplasty components as per standard surgical care and routine postoperative rehabilitation. | Procedure or surgery | Operative Course for rTSA |
| Nonoperative TreatmentSubjects allocated to the nonoperative treatment arm will maintain sling immobilization for 3 weeks. The sling will be removed for elbow, wrist and hand range of motion (ROM), hygiene, and dressing only. At 3 weeks passive ROM in external rotation (ER) and forward elevation (FE) will be added. At 6 weeks from injury, the sling will be removed and stretching in all planes will be allowed. Use of the arm will be up to a fork/knife/toothbrush only. At 3 months from injury, strengthening will be added. Supervised physical therapy will be offered to patients for use at their discretion, as is current practice. | Other | Nonoperative Treatment |
Primary outcome
Function as described by ASES score at 1 year follow-up.
Time frame: 2 year follow-up
The American Shoulder and Elbow Surgeons (ASES) score is a well-validated, patient-reported outcome measure used by shoulder and elbow surgeons. The score ranges from 0-100 with 100 signifying the best outcome. Half of the score correlates to pain and half to function, both on a 0-50 scale where higher is again considered a better outcome. The pain portion is tabulated by taking the patient's response on a visual analogue scale (0 to 10 scale where 0 represent no pain and 10 represents worst pain imaginable), subtracting it from 10, and then multiplying by 5. The function score is tabulated by taking the patient's response on 10 questions rated on an ordinal scale from 0-3 and then multiplying the cumulative score by 5/3.
Results and safety
The study was stopped early (reason given: Slower than expected enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Jonathan D Barlow 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 Reverse Total Shoulder Arthroplasty (rTSA) and Nonoperative Treatment in people with Humerus Fracture and Humerus, 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 2 inclusion and 6 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 11 Oct 2021. 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: Slower than expected enrollment.). 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?
Function as described by ASES score at 1 year follow-up. (time frame: 2 year follow-up). 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 NCT03599336, 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 11 Oct 2021.