Proximal Humeral FractureNCT04786639
Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
An observational study of Proximal Humeral Fracture, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The management of proximal humerus fractures (PHFs) remains a significant challenge in orthopaedics. The acute treatment options for PHFs are numerous and are typically guided by the fracture pattern and functional demands of the patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Proximal Humeral Fracture
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2021to 15 May 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients with proximal humerus fracture who come to the orthopedic clinic.
Who may be able to join
- Stabilization after proximal humerus fracture with surgical fixation (post-op 3-6 weeks) or non-surgical treatment with sling immobilization (callus formation on radiography).
- Volunteer
Who cannot join
- Malunion tubercle majus,
- Advanced osteoporosis,
- Avascular necrosis of the humeral head,
- Presence of neurological and rheumatologic disease,
- Recurrent infection and open wound-incision in the region,
- Communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
The management of proximal humerus fractures (PHFs) remains a significant challenge in orthopaedics. The acute treatment options for PHFs are numerous and are typically guided by the fracture pattern and functional demands of the patients. The most commonly used methods include non-operative management with a sling or surgical fixation. Although non-surgical treatment is a reasonable treatment option for the majority of humerus fractures, there is an increasing interest in surgical intervention. There are no evidence-based treatment recommendations, thus permitting large local variation in treatment preferences.
There are a number of studies in the literature about how outcome measures of the patients after PHFs management change, but these results generally compare functional results before and after treatment. Misra et al. stated that conservatively managed patients with PHFs have more pain and a poorer range of motion than those managed by either fixation or arthroplasty, while cochrane review stated that surgery is not superior to nonsurgical treatment in most proximal humerus fractures. Jayakumar et al. determined that kinesiophobia is one of the strongest predictors of functional limitation and recovery from a PHF is enhanced by overcoming fears of movement or reinjury within a week after injury.
There is no clear knowledge regarding how the surgical or conservative management used in the management of PHF affects the early results of assessment parameters. The aim of this study was to compare early results of surgical fixation versus non-operative management outcomes in patients with proximal humerus fractures.
Read the detailed description
Voluntary patients who have been diagnosed with proximal humerus fracture and managed by surgical or conservative will be included in the study.
Patients with stabilization after proximal humerus fracture with surgical fixation will be considered as the Surgery group, and patients treated with non-surgical treatment with sling immobilization will be considered as the Conservative group. Signed voluntary consent will be obtained from participants. Patients having surgical fixation or nonoperative management will be assessed for kinesiophobia, pain, range of motion, functional status, and quality of life.
- Conditions
- Proximal Humeral Fracture
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Fixation Group | Open reduction with deltopectoral incision and humeral osteosynthesis with anatomic plates and screws will be performed for surgical fixation. | |
| Non-Operative Group | Non-surgical treatment will be performed with sling immobilization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
Tampa kinesiophobia scale will be used for determining of kinesiophobia or fear of movement.The Tampa Scale for Kinesiophobia is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The score varies between 17 and high scores indicate an increasing degree of kinesiophobia.
Measured: Baseline
Secondary outcomes (4)
Shoulder Pain
A Visual Analogue Scale will be used for pain of rest, night and activity. It is a scale measuring the distance (mm) on the 10-cm line between the "no pain" (0) and and " worst pain (10).
Measured: Baseline
Range of Motion
Shoulder flexion, extension, external and internal rotation will be measured by using digital goniometer. It is a reliable and valid tool for measuring shoulder range of motion in individuals with healthy shoulders. Increasing the degree is considered as an improvement in the range of motion.
Measured: Baseline
Functional Status
The Disabilities of the Arm, Shoulder and Hand questionnaire will be used for measuring of self-rated upper-extremity disability and symptoms. The scale score ranging is from 0 (no disability) to 100 (most severe disability).
Measured: Baseline
Quality of Life of the patients
The quality of life will be assessed by using 36-Item Short Form Survey. The survey has eight sub scaled scores; vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Scores range from 0 - 100 and higher scores shows less disability.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start12 Mar 2021
- Primary completion12 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
- Investigators
- Ayse Zengin Alpozgen, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786639
- Sponsor's protocol ID
- IUC1
- Status last verified
- Jul 2023
- First submitted
- 3 Mar 2021
- Last updated
- 19 Jul 2023
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT04786639
- Acronym / sponsor ID
- IUC1
- Conditions
- Proximal Humeral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 8 Mar 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.
The management of proximal humerus fractures (PHFs) remains a significant challenge in orthopaedics. The acute treatment options for PHFs are numerous and are typically guided by the fracture pattern and functional demands of the patients. The most commonly used methods include non-operative management with a sling or surgical fixation. Although non-surgical treatment is a reasonable treatment option for the majority of humerus fractures, there is an increasing interest in surgical intervention. There are no evidence-based treatment recommendations, thus permitting large local variation in treatment preferences.
There are a number of studies in the literature about how outcome measures of the patients after PHFs management change, but these results generally compare functional results before and after treatment. Misra et al. stated that conservatively managed patients with PHFs have more pain and a poorer range of motion than those managed by either fixation or arthroplasty, while cochrane review stated that surgery is not superior to nonsurgical treatment in most proximal humerus fractures. Jayakumar et al. determined that kinesiophobia is one of the strongest predictors of functional limitation and recovery from a PHF is enhanced by overcoming fears of movement or reinjury within a week after injury.
There is no clear knowledge regarding how the surgical or conservative management used in the management of PHF affects the early results of assessment parameters. The aim of this study was to compare early results of surgical fixation versus non-operative management outcomes in patients with proximal humerus fractures.
Detailed description
Voluntary patients who have been diagnosed with proximal humerus fracture and managed by surgical or conservative will be included in the study.
Patients with stabilization after proximal humerus fracture with surgical fixation will be considered as the Surgery group, and patients treated with non-surgical treatment with sling immobilization will be considered as the Conservative group. Signed voluntary consent will be obtained from participants. Patients having surgical fixation or nonoperative management will be assessed for kinesiophobia, pain, range of motion, functional status, and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Fixation Group | – | –Open reduction with deltopectoral incision and humeral osteosynthesis with anatomic plates and screws will be performed for surgical fixation. |
| Non-Operative Group | – | –Non-surgical treatment will be performed with sling immobilization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with proximal humerus fracture who come to the orthopedic clinic.
Key inclusion criteria (2 listed)
- Stabilization after proximal humerus fracture with surgical fixation (post-op 3-6 weeks) or non-surgical treatment with sling immobilization (callus formation on radiography).
- Volunteer
Key exclusion criteria (6 listed)
- Malunion tubercle majus,
- Advanced osteoporosis,
- Avascular necrosis of the humeral head,
- Presence of neurological and rheumatologic disease,
- Recurrent infection and open wound-incision in the region,
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
Kinesiophobia
Time frame: Baseline
Tampa kinesiophobia scale will be used for determining of kinesiophobia or fear of movement.The Tampa Scale for Kinesiophobia is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The score varies between 17 and high scores indicate an increasing degree of kinesiophobia.
4 secondary outcomes
Shoulder Pain
Time frame: Baseline
Range of Motion
Time frame: Baseline
Functional Status
Time frame: Baseline
Quality of Life of the patients
Time frame: Baseline
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 19 Jul 2023.
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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.
Ayse Zengin Alpozgen, PhD principal investigator
Istanbul University - Cerrahpasa
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 Humeral Fracture, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 19 Jul 2023. 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 Turkey (Türkiye). 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 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?
Kinesiophobia (time frame: Baseline). 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 Jul 2023.