Proximal Humerus FracturesSPHEERNCT05005364
Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus Fractures.
An observational study of Proximal Humerus Fractures, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
With an ageing population, fragility fractures secondary to osteoporosis are on a increasing trend. Proximal humerus fractures are common fractures which account for a significant proportion of these fragility fractures. They significantly affect patients function and independence particularly in the elderly. Read more about this study
- Who is it for?
- Ages 21 to 110 years
- Conditions the study is for
- Proximal Humerus Fractures
- How many people
- 400 participants
- Where
- 1 siteSingapore
- Study dates
- 21 Aug 2017to 31 Dec 2023
- Phase
- Observational
- 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 21 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with proximal humerus fracture going for surgical or conservative treatment option
Who may be able to join
- Age 21 years old and above
- Radiologically confirmed proximal humerus fracture
- Within 3 weeks of their injury
Who cannot join
- Open fracture
- Mentally incompetent patients
- Co-morbidities precluding anaesthesia
- Severe soft tissue compromise
- Neurovascular compromise
- Pathological fracture other than osteoporosis
- Surgery delayed > 3 weeks
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore
Bryan Tan, 63577713, bryan_tan@whc.sg
About this study
With an ageing population, fragility fractures secondary to osteoporosis are on a increasing trend. Proximal humerus fractures are common fractures which account for a significant proportion of these fragility fractures. They significantly affect patients function and independence particularly in the elderly.
Currently, treatment options range from conservative treatment with an arm sling to fixation either with plates or intramedullary devices to arthroplasty ranging from a hemiarthroplasty to the latest reverse shoulder arthroplasty. While is there has been a global trend towards surgical treatment for such fractures, there is significant controversy regarding the best treatment with many studies reporting disappointing functional outcomes including residual shoulder pain, limitation in shoulder motion and decreased quality of life regardless of treatment option selected.
Read more
In this day and age where healthcare cost is a big concern both at the individual patient level but at a government level as well, evaluating the cost effectiveness of treatment becomes essential as well. Currently in Singapore, there have been a significant trend of an increased use of surgical treatment of proximal humerus fractures however we have very little data in our local context not only to evaluate the clinical effectiveness but also the cost effectiveness of surgical treatment in comparison to conservative treatment.
The primary aim of the study is
- To understand the epidemiology and prognostic factors for proximal humerus fractures
- Incidence
- Health service utilization
- clinical and functional outcomes
- To estimate the relative cost-effectiveness of surgical vs non-surgical treatment pathways for managing patients with proximal humerus fractures.
We hypothesize that surgical fixation of the proximal humerus is both clinically and cost effective
- Conditions
- Proximal Humerus Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Shoulder Score - change over 6 weeks, 3, 6, 12 months
To evaluate the clinical outcomes over time by comparing the change in constant shoulder score over a period of 1 year. The Constant Shoulder Score is used to assess the level of pain and the patient's ability to carry out normal daily activities.
Constant score of the unaffected shoulder was also assessed at baseline to compare the function between the two shoulders.
Measured: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
Oxford Shoulder Score - change over 6 weeks, 3, 6, 12 months
A 12-item patient-report questionnaire developed to evaluate the outcome of shoulder surgery, excluding surgery for instability. The OSS contains two subscales, pain and activities of daily living. Each responses is of a 0-4 scoring format with a higher score representing better function. Hence, the highest possible total score is 48 and a higher score represents a better outcome.
Measured: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
QuickDASH scoring - change over 6 weeks, 3, 6, 12 months
This score is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).
Measured: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary outcomes (2)
EQ5D-5L - change over 6 weeks, 3, 6, 12 months
EuroQol-5 Dimensions (EQ-5D) consists of 2 dimensions, the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by selecting the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS will be used as a quantitative measure of health outcome.
Measured: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
Costing questionnaire
Questionnaire measuring the direct and indirect costs
Measured: Assessed at 6 weeks, 3 months, 4.5 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start21 Aug 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humerus 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Tan, Tan Tock Seng Hospital
- Investigators
- Bryan Tan, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005364
- Sponsor's protocol ID
- 2016/01241
- Other IDs
- 2016
- Acronym
- SPHEER
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Clinical Profile and Treatment Outcomes of Proximal Humerus Fractures.
- ClinicalTrials.gov ID
- NCT05005364
- Acronym / sponsor ID
- SPHEER / 2016/01241
- Conditions
- Proximal Humerus Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Aug 2021 (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.
With an ageing population, fragility fractures secondary to osteoporosis are on a increasing trend. Proximal humerus fractures are common fractures which account for a significant proportion of these fragility fractures. They significantly affect patients function and independence particularly in the elderly.
Currently, treatment options range from conservative treatment with an arm sling to fixation either with plates or intramedullary devices to arthroplasty ranging from a hemiarthroplasty to the latest reverse shoulder arthroplasty. While is there has been a global trend towards surgical treatment for such fractures, there is significant controversy regarding the best treatment with many studies reporting disappointing functional outcomes including residual shoulder pain, limitation in shoulder motion and decreased quality of life regardless of treatment option selected.
In this day and age where healthcare cost is a big concern both at the individual patient level but at a government level as well, evaluating the cost effectiveness of treatment becomes essential as well. Currently in Singapore, there have been a significant trend of an increased use of surgical treatment of proximal humerus fractures however we have very little data in our local context not only to evaluate the clinical effectiveness but also the cost effectiveness of surgical treatment in comparison to conservative treatment.
The primary aim of the study is
- To understand the epidemiology and prognostic factors for proximal humerus fractures
- Incidence
- Health service utilization
- clinical and functional outcomes
- To estimate the relative cost-effectiveness of surgical vs non-surgical treatment pathways for managing patients with proximal humerus fractures.
We hypothesize that surgical fixation of the proximal humerus is both clinically and cost effective
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with proximal humerus fracture going for surgical or conservative treatment option
Key inclusion criteria (3 listed)
- Age 21 years old and above
- Radiologically confirmed proximal humerus fracture
- Within 3 weeks of their injury
Key exclusion criteria (8 listed)
- Open fracture
- Mentally incompetent patients
- Co-morbidities precluding anaesthesia
- Severe soft tissue compromise
- Neurovascular compromise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Constant Shoulder Score - change over 6 weeks, 3, 6, 12 months
Time frame: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
To evaluate the clinical outcomes over time by comparing the change in constant shoulder score over a period of 1 year. The Constant Shoulder Score is used to assess the level of pain and the patient's ability to carry out normal daily activities. Constant score of the unaffected shoulder was also assessed at baseline to compare the function between the two shoulders.
Oxford Shoulder Score - change over 6 weeks, 3, 6, 12 months
Time frame: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
A 12-item patient-report questionnaire developed to evaluate the outcome of shoulder surgery, excluding surgery for instability. The OSS contains two subscales, pain and activities of daily living. Each responses is of a 0-4 scoring format with a higher score representing better function. Hence, the highest possible total score is 48 and a higher score represents a better outcome.
QuickDASH scoring - change over 6 weeks, 3, 6, 12 months
Time frame: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
This score is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability).
2 secondary outcomes
EQ5D-5L - change over 6 weeks, 3, 6, 12 months
Time frame: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months
Costing questionnaire
Time frame: Assessed at 6 weeks, 3 months, 4.5 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
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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.
Bryan Tan principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humerus Fractures, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 8 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: status not confirmed, as of the sponsor's last update on 13 Aug 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bryan Tan (63577713, bryan_tan@whc.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Shoulder Score - change over 6 weeks, 3, 6, 12 months (time frame: Assessed at baseline, 6 weeks, 3 months, 6 months, 12 months). The study lists 3 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 13 Aug 2021.