Shoulder FracturesNCT06360887
Management of Proximal Humerus Fractures in Adults: a Clinical Trial
An observational study of Shoulder Fractures, run by Regional Hospital of Bolzano at 1 site in Italy.
Trial summary
Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Fractures
- What is being tested?
- Conservative, ORIF and CRPP
- Type of treatment
- Surgery or procedure
- How many people
- 351 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2024to 31 Jan 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults presenting at our hospital with proximal humerus fractures that meet the inclusion and exclusion criteria
Who may be able to join
- adults who sustained a Proximal Humerus Fracture within the last week
- type of Proximal Humerus Fracture AO 11-(A2, A3), 11- (B1, B2, B3)
- BMI lower than 40 Kg/m2
Who cannot join
- stress fractures
- revision setting
- open fractures
- fractures associated with a neurologic lesion; previous fractures or bony procedure at the homolateral side
- patients unable to understand the procedure or instructions for rehabilitation
- terminal patients
- patients presenting multiple injuries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Academic Hospital of Bolzano (SABES-ASDAA)
Bolzano, Trentino-Alto Adige, 39100
Malte Nikolas Witte, Dr., 00393885787726, maltewitte@posteo.de
About this study
Official title: Management of Proximal Humerus Fractures in Elderlies: a Clinical Trial
Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment.
Read the detailed description
The present study shall be conducted in accordance with the SPIRIT 2013 statement: defining standard protocol items for clinical trials. All patients who sustained a PHF and presented at the Department of Orthopedics at the Academic Hospital of Bolzano (Italy) will be prospectively incited to participate in the present clinical trial. Patient recruitment will begin in April 2024, and end in April 2026. The follow-up period will start in October 2024, and end in April 2028. Data analysis will commence in October 2024 and end in April 2028. The present study shall be conducted according to the principles of the Declaration of Helsinki. The authors receive no financial support for the research, authorship, and/or publication of this article. The protocol of the study has been prospectively registered and approved by the German Registry of Clinical Trials (ID DRKS00030614). Ethics approval has been received from the Ethic Committee of the South Tyrolean Health Authority, Bolzano, Italy (ID 2022374 of June 22, 2023). All surgical and conservative procedures under analysis are already routinely carried out at the Department of Orthopaedics and Trauma Surgery of the Academic Hospital of Bolzano, Italy. Patients who meet the inclusion criteria and agree to participate in the study by signing the consent form and the personal data processing form will be included in the study.
Data curation Personal data, including sensitive data, will be pseudonymised and associated with a code from which it will be impossible to trace the patient's identity. Only the Principal Investigator and sub-investigators of the study will be able to link the code to the name. The pseudonymised data will be collected in a table of Microsoft Office Excel version 16 (Microsoft Corporation, Redmond, US).
Statistical analyses Assuming an actual difference in means between the test and reference group of 3 units and a pooled standard deviation of 5 units, the study would require a sample size of 117 patients for each group (i.e. a total sample size of 351, assuming equal group size), to obtain a power of 80% and a significance level of 5%, to declare the superiority of a technique with a margin of prominence of 5 units, assuming a minimum clinically important difference OSS of 2.7/100 .
- Conditions
- Shoulder Fractures
- Being tested
- Conservative, ORIF, CRPP
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConservativeProcedure or surgery
Conservative treatment
ORIFProcedure or surgery
Open surgery
CRPPProcedure or surgery
Minimal invasive surgery
| Study group | Role | What they receive |
|---|---|---|
| Conservative | Participants allocated to conservative management will receive an orthosis (Gilchrist) for a minimum of four weeks. Using Gilchrist, the upper arm of the injured side is secured in abduction and internal rotation with the weight of the arm held by a ring around the patient's neck. At four weeks, plain radiographs of the shoulder will be conducted to ascertain the presence of the bony callous. If a bony callous is not present, the patient will maintain Gilchrist and plain radiographs of the shoulder will be conducted on a biweekly basis until a bony callous will be evident. If a bony callous is present, the patient will start a structured program of rehabilitation. Receives: Procedure: Conservative | |
| Open Reduction Internal Fixation | Participants allocated to ORIF will undergo surgery within 72 hours from the diagnosis using a standard deltopectoral approach. An angular stable plate is used in all patients following manufacturer instructions. No drains will be used. Receives: Procedure: ORIF | |
| Closed Reduction Percutaneous Pinning | Participants allocated to CRPP will be positioned in a beach chair under total anesthesia. The fracture is repositioned under fluoroscopic guidance using manual traction. The osteosynthesis is then done using Kirschner wires.The arm is placed into a Gilchrist for four weeks. At four weeks, plain radiographs of the shoulder will be conducted to ascertain the presence of the bony callous. If a bony callous is not present, the patient will maintain Gilchrist and plain radiographs of the shoulder will be conducted on a biweekly basis until a bony callous will be evident. If a bony callous is present, the Kirschner wires will be removed and the patient will start a structured program of rehabilitation. Receives: Procedure: CRPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Shoulder Score
The primary endpoint of interest will be the Oxford Shoulder Score. The Oxford Shoulder Score is a patient-reported outcome measure developed to evaluate perceived pain and quality of life in subjects who received a shoulder operation. It can be used independently from the performed surgical treatment, excluding only surgical stabilisations. As the Italian province of Bolzano is bilingual (Italian and German), the Italian and German versions of the Oxford Shoulder Score shall be administered. Both versions of the Oxford Shoulder Score are valid and reliable, with high internal consistency and reproducibility. The Oxford Shoulder Score comprises 12 items with five possible answers each: pain (four items) and quality of life (eight items).
The Oxford Shoulder Score contains two subscales, pain (20 points) and activities of daily living (40 points). Scores range from 0 to 60, with a higher score being consistent with increased disability.
Measured: 6, 12, and 24 months after surgery
Secondary outcomes (2)
The visual analogue scale
The visual analogue scale (VAS) is a scale used to determine the pain intensity. The minimum value is 0, the maximum value is 10, with 0 meaning no pain and 10 the worst pain imaginable.
Measured: 6, 12, and 24 months after surgery
Rate of complications
persistent pain, frozen shoulder, malunion, surgery, nerve damage
Measured: 6, 12, and 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study startApr 2024 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- 351 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Regional Hospital of Bolzano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malte Nikolas Witte, Regional Hospital of Bolzano
- Investigators
- Filippo Migliorini, Dr., Principal investigator, employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360887
- Sponsor's protocol ID
- DRKS00030614
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Proximal Humerus Fractures in Elderlies: a Clinical Trial
- ClinicalTrials.gov ID
- NCT06360887
- Acronym / sponsor ID
- DRKS00030614
- Conditions
- Shoulder Fractures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 351 participants (estimated)
- Lead sponsor
- Regional Hospital of BolzanoUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 11 Apr 2024 (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.
Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment.
Detailed description
The present study shall be conducted in accordance with the SPIRIT 2013 statement: defining standard protocol items for clinical trials. All patients who sustained a PHF and presented at the Department of Orthopedics at the Academic Hospital of Bolzano (Italy) will be prospectively incited to participate in the present clinical trial. Patient recruitment will begin in April 2024, and end in April 2026. The follow-up period will start in October 2024, and end in April 2028. Data analysis will commence in October 2024 and end in April 2028. The present study shall be conducted according to the principles of the Declaration of Helsinki. The authors receive no financial support for the research, authorship, and/or publication of this article. The protocol of the study has been prospectively registered and approved by the German Registry of Clinical Trials (ID DRKS00030614). Ethics approval has been received from the Ethic Committee of the South Tyrolean Health Authority, Bolzano, Italy (ID 2022374 of June 22, 2023). All surgical and conservative procedures under analysis are already routinely carried out at the Department of Orthopaedics and Trauma Surgery of the Academic Hospital of Bolzano, Italy. Patients who meet the inclusion criteria and agree to participate in the study by signing the consent form and the personal data processing form will be included in the study.
Data curation Personal data, including sensitive data, will be pseudonymised and associated with a code from which it will be impossible to trace the patient's identity. Only the Principal Investigator and sub-investigators of the study will be able to link the code to the name. The pseudonymised data will be collected in a table of Microsoft Office Excel version 16 (Microsoft Corporation, Redmond, US).
Statistical analyses Assuming an actual difference in means between the test and reference group of 3 units and a pooled standard deviation of 5 units, the study would require a sample size of 117 patients for each group (i.e. a total sample size of 351, assuming equal group size), to obtain a power of 80% and a significance level of 5%, to declare the superiority of a technique with a margin of prominence of 5 units, assuming a minimum clinically important difference OSS of 2.7/100 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative | – | Procedure: ConservativeParticipants allocated to conservative management will receive an orthosis (Gilchrist) for a minimum of four weeks. Using Gilchrist, the upper arm of the injured side is secured in abduction and internal rotation with the weight of the arm held by a ring around the patient's neck. At four weeks, plain radiographs of the shoulder will be conducted to ascertain the presence of the bony callous. If a bony callous is not present, the patient will maintain Gilchrist and plain radiographs of the shoulder will be conducted on a biweekly basis until a bony callous will be evident. If a bony callous is present, the patient will start a structured program of rehabilitation. |
| Open Reduction Internal Fixation | – | Procedure: ORIFParticipants allocated to ORIF will undergo surgery within 72 hours from the diagnosis using a standard deltopectoral approach. An angular stable plate is used in all patients following manufacturer instructions. No drains will be used. |
| Closed Reduction Percutaneous Pinning | – | Procedure: CRPPParticipants allocated to CRPP will be positioned in a beach chair under total anesthesia. The fracture is repositioned under fluoroscopic guidance using manual traction. The osteosynthesis is then done using Kirschner wires.The arm is placed into a Gilchrist for four weeks. At four weeks, plain radiographs of the shoulder will be conducted to ascertain the presence of the bony callous. If a bony callous is not present, the patient will maintain Gilchrist and plain radiographs of the shoulder will be conducted on a biweekly basis until a bony callous will be evident. If a bony callous is present, the Kirschner wires will be removed and the patient will start a structured program of rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting at our hospital with proximal humerus fractures that meet the inclusion and exclusion criteria
Key inclusion criteria (3 listed)
- adults who sustained a Proximal Humerus Fracture within the last week
- type of Proximal Humerus Fracture AO 11-(A2, A3), 11- (B1, B2, B3)
- BMI lower than 40 Kg/m2
Key exclusion criteria (7 listed)
- stress fractures
- revision setting
- open fractures
- fractures associated with a neurologic lesion; previous fractures or bony procedure at the homolateral side
- patients unable to understand the procedure or instructions for rehabilitation
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 |
|---|---|---|
| ConservativeConservative treatment | Procedure or surgery | Conservative |
| ORIFOpen surgery | Procedure or surgery | Open Reduction Internal Fixation |
| CRPPMinimal invasive surgery | Procedure or surgery | Closed Reduction Percutaneous Pinning |
Primary outcome
Oxford Shoulder Score
Time frame: 6, 12, and 24 months after surgery
The primary endpoint of interest will be the Oxford Shoulder Score. The Oxford Shoulder Score is a patient-reported outcome measure developed to evaluate perceived pain and quality of life in subjects who received a shoulder operation. It can be used independently from the performed surgical treatment, excluding only surgical stabilisations. As the Italian province of Bolzano is bilingual (Italian and German), the Italian and German versions of the Oxford Shoulder Score shall be administered. Both versions of the Oxford Shoulder Score are valid and reliable, with high internal consistency and reproducibility. The Oxford Shoulder Score comprises 12 items with five possible answers each: pain (four items) and quality of life (eight items). The Oxford Shoulder Score contains two subscales, pain (20 points) and activities of daily living (40 points). Scores range from 0 to 60, with a higher score being consistent with increased disability.
2 secondary outcomes
The visual analogue scale
Time frame: 6, 12, and 24 months after surgery
Rate of complications
Time frame: 6, 12, and 24 months after surgery
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 12 Apr 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Filippo Migliorini, Dr. principal investigator
employee
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 Shoulder Fractures, run by Regional Hospital of Bolzano at 1 site in Italy.
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 7 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 12 Apr 2024. 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 Italy. 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 Malte Nikolas Witte, Dr. (00393885787726, maltewitte@posteo.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Shoulder Score (time frame: 6, 12, and 24 months after surgery). 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 12 Apr 2024.