Proximal Humerus FractureNCT07060664
Study on Outcomes of Proximal Humerus Fractures
A study testing open reduction internal fixation, intramedullary nail and reverse total shoulder arthroplasty in people with Proximal Humerus Fracture, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Patients undergoing either operative or non-operative treatment of proximal humerus fractures will be studied with the goal of understanding which treatment modality provides optimal post-injury outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Proximal Humerus Fracture
- What is being tested?
- open reduction internal fixation, intramedullary nail and reverse total shoulder arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2027to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- individuals 65 years of age or older with proximal humerus fractures
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01605
Gregory Iovanel, MD, 401-651-8188, iovanel.gregory@gmail.com
About this study
Official title: Review of Proximal Humerus Fracture Outcomes
Patients undergoing either operative or non-operative treatment of proximal humerus fractures will be studied with the goal of understanding which treatment modality provides optimal post-injury outcomes.
- Conditions
- Proximal Humerus Fracture
- Being tested
- open reduction internal fixation, intramedullary nail, reverse total shoulder arthroplasty
- Keywords
- proximal humerus fracture, humerus, fracture, shoulder, ORIF, IMN, nail, open reduction internal fixation
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reduction internal fixationProcedure or surgery
Also called ORIF
treatment with open reduction and plates/screws
intramedullary nailProcedure or surgery
Also called IMN
open reduction and intramedullary nail
reverse total shoulder arthroplastyProcedure or surgery
Also called RTSA
reverse total shoulder arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Operative Management | Active comparator | Not described Receives: Procedure: open reduction internal fixation; Procedure: intramedullary nail; Procedure: reverse total shoulder arthroplasty |
| Non-operative Management | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion (ROM)
Range of Motion of the shoulder in terms of degrees of motion
Assessment of forward flexion (0-180 degrees), abduction (0-90 degrees), external rotation (0-90 degrees)
Measured: at 3 months, 6 months, 12 months, and 24 months from initiation of treatment
SANE
"Sane outcome" typically refers to the Single Assessment Numeric Evaluation (SANE) score, a patient-reported outcome measure used in healthcare, particularly in orthopedics. It assesses a patient's perceived function of a joint or body region by asking them to rate it on a scale of 0 to 100, where 100 represents normal function
Measured: at 3 months, 6 months, 12 months, and 24 months following initiation of treatment
VAS
"VAS outcome" refers to the results obtained from using a Visual Analog Scale (VAS). The VAS is a measurement tool, typically a 10 cm or 100 mm line, where individuals indicate the intensity of a subjective experience, such as pain, by marking a point on the line. The distance from one end of the line to the patient's mark is then measured, and this measurement represents the VAS score. A higher score indicates a greater intensity of the experience being measured.
Measured: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
ASES
The American Shoulder and Elbow Surgeons scale (ASES) is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder. A higher ASES score indicates better shoulder function and less pain, with a score of 100 representing the best possible outcome and a score of 0 representing the worst possible outcome.
Measured: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
EQ-5D-5L
The EQ-5D-5L score represents a patient's self-reported health status, with values ranging from -0.59 to 1, where 1 indicates the best possible health. It's based on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. These responses are converted into a single index score using a scoring algorithm.
Measured: at baseline and subsequently at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
Brophy/Marx
The Brophy-Marx Shoulder Activity Score is a valid and reliable shoulder-specific questionnaire that measures a patient's shoulder activity level over the previous year. The questionnaire generates a numeric score from 0 (least active) to 20 (most active).
Measured: at baseline and subsequently at 12 months and 24 months after initiation of intervention
PROMIS Social
PROMIS, or the Patient-Reported Outcomes Measurement Information System, uses T-scores to represent social health, with a mean of 50 and a standard deviation of 10 for the general US population. Higher T-scores generally indicate a greater amount of the measured concept, such as satisfaction with social roles and activities, while lower scores indicate less.
Measured: at 3 months, 12 months, and 24 months following initiation of intervention
Radiographic Outcome
evidence of bony healing, nonunion, or malunion of the fracture on imaging
Measured: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
Complication Rate
Rate of complications following initiation of management
Measured: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Sep 2027 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humerus FractureStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Iovanel, University of Massachusetts, Worcester
- Investigators
- Wayne Chan, MD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060664
- Sponsor's protocol ID
- 00002567
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of Proximal Humerus Fracture Outcomes
- ClinicalTrials.gov ID
- NCT07060664
- Acronym / sponsor ID
- 00002567
- Conditions
- Proximal Humerus Fracture
- Keywords
- proximal humerus fracture, humerus, fracture, shoulder, ORIF, IMN, nail, open reduction internal fixation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 11 Jul 2025 (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.
Patients undergoing either operative or non-operative treatment of proximal humerus fractures will be studied with the goal of understanding which treatment modality provides optimal post-injury outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operative Management | Active comparator | Procedure: open reduction internal fixation, Procedure: intramedullary nail, Procedure: reverse total shoulder arthroplasty |
| Non-operative Management | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- individuals 65 years of age or older with proximal humerus fractures
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| open reduction internal fixationAlso: ORIFtreatment with open reduction and plates/screws | Procedure or surgery | Operative Management |
| intramedullary nailAlso: IMNopen reduction and intramedullary nail | Procedure or surgery | Operative Management |
| reverse total shoulder arthroplastyAlso: RTSAreverse total shoulder arthroplasty | Procedure or surgery | Operative Management |
Primary outcome
Range of Motion (ROM)
Time frame: at 3 months, 6 months, 12 months, and 24 months from initiation of treatment
Range of Motion of the shoulder in terms of degrees of motion Assessment of forward flexion (0-180 degrees), abduction (0-90 degrees), external rotation (0-90 degrees)
SANE
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of treatment
"Sane outcome" typically refers to the Single Assessment Numeric Evaluation (SANE) score, a patient-reported outcome measure used in healthcare, particularly in orthopedics. It assesses a patient's perceived function of a joint or body region by asking them to rate it on a scale of 0 to 100, where 100 represents normal function
VAS
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
"VAS outcome" refers to the results obtained from using a Visual Analog Scale (VAS). The VAS is a measurement tool, typically a 10 cm or 100 mm line, where individuals indicate the intensity of a subjective experience, such as pain, by marking a point on the line. The distance from one end of the line to the patient's mark is then measured, and this measurement represents the VAS score. A higher score indicates a greater intensity of the experience being measured.
ASES
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
The American Shoulder and Elbow Surgeons scale (ASES) is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder. A higher ASES score indicates better shoulder function and less pain, with a score of 100 representing the best possible outcome and a score of 0 representing the worst possible outcome.
EQ-5D-5L
Time frame: at baseline and subsequently at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
The EQ-5D-5L score represents a patient's self-reported health status, with values ranging from -0.59 to 1, where 1 indicates the best possible health. It's based on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. These responses are converted into a single index score using a scoring algorithm.
Brophy/Marx
Time frame: at baseline and subsequently at 12 months and 24 months after initiation of intervention
The Brophy-Marx Shoulder Activity Score is a valid and reliable shoulder-specific questionnaire that measures a patient's shoulder activity level over the previous year. The questionnaire generates a numeric score from 0 (least active) to 20 (most active).
PROMIS Social
Time frame: at 3 months, 12 months, and 24 months following initiation of intervention
PROMIS, or the Patient-Reported Outcomes Measurement Information System, uses T-scores to represent social health, with a mean of 50 and a standard deviation of 10 for the general US population. Higher T-scores generally indicate a greater amount of the measured concept, such as satisfaction with social roles and activities, while lower scores indicate less.
Radiographic Outcome
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
evidence of bony healing, nonunion, or malunion of the fracture on imaging
Complication Rate
Time frame: at 3 months, 6 months, 12 months, and 24 months following initiation of intervention
Rate of complications following initiation of management
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Wayne Chan, MD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open reduction internal fixation, intramedullary nail and reverse total shoulder arthroplasty in people with Proximal Humerus Fracture, run by University of Massachusetts, Worcester 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Iovanel, MD (401-651-8188, iovanel.gregory@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (ROM) (time frame: at 3 months, 6 months, 12 months, and 24 months from initiation of treatment). The study lists 9 primary outcomes in all. 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 19 Oct 2026.