Proximal Humeral FractureNCT06444828
Comparing Outcomes of Non-surgical Versus Surgical Treatment of Shoulder Fractures With Different Shoulder Replacements
A study testing Non-operative in people with Proximal Humeral Fracture and Humeral Head Fracture, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The optimal treatment of complex shoulder fracture is controversial. In general, non-surgical treatment is recommended for older patients, but results are often unsatisfying. Therefore different surgical approaches have been tried to improve outcomes for this group of patients. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Proximal Humeral Fracture, Humeral Head Fracture
- What is being tested?
- Non-operative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 1 Sep 2026
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Displaced Proximal Humeral Fractures (PHF) Neer type III or IV / AO B\&C. Radiological confirmed
Who cannot join
- other types of PHF, Head splits, gleno-humeral dislocations, pathological fractures. Refuse to participate in the study. Non-compliant, drug/alcohol abuse or institutionalized, (Low-cooperative),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome Following Reverse Shoulder Arthroplasty for Acute Proximal Humerus Fractures in Patients 60 Years of Age and Older With Different Inclination Implants Versus Non-surgical Treatment- Trial Protocol: a Prospective RCT, Single Blinded
The optimal treatment of complex shoulder fracture is controversial. In general, non-surgical treatment is recommended for older patients, but results are often unsatisfying. Therefore different surgical approaches have been tried to improve outcomes for this group of patients. Reverse shoulder arthroplasty has shown promising results for these types of fractures and changes in the design of the implant might improve outcomes further. The aim of this study is to compare the outcomes of complex shoulder fractures after non-surgical versus surgical treatment and compare two different types of implants.
Read the detailed description
The optimal treatment of proximal humeral fracture (PHF) Neer type III and IV AO B1.1,1.2 and C1.1,3.1 is controversial. National guidelines for Denmark have been published in 2015 and updated 2019. They recommend conservative treatment to all kinds of PHF for patients aged above 60 years. Exceptions are fracture-dislocations, headsplits or surgical conditions, where intervention is mandatory like open fractures and impaired nerve- and circulation.
Recently reverse shoulder arthroplasty (RSA) has gained expanding popularity in treating PHF . Compared with osteosynthesis (ORIF) or hemiarthroplasty (HA) outcomes were superior , . The importance of tuberosity healing for good functional outcomes has lead to development of different implants and fixation techniques. The original RSA design by Grammont with 155 degree inclination of the humeral stem was made for cuff-arthropathy. This design moves the center of rotation in a medial direction, and increase the tension on the tuberosities.
In contrast "anatomical" designed humeral implants with 135 degree enables more anatomical refixation of the tuberosities with less tension and might reduce the risk of resorption or displacement of the fragments. To implant a 155 degree RSA the surgeon has to remove parts of the rotator cuff, to enable the sliding rotation. On the other hand with a 135 degree inclination humeral component, a cuff sparing technique is possible.
The aim of this study is to compare outcomes of two different designed RSA stems versus conservative treatment of PHF Neer type III or IV / AO B\&C.
- Conditions
- Proximal Humeral Fracture, Humeral Head Fracture
- Being tested
- Non-operative
- Keywords
- proximal humerus fracture, Reverse Shoulder Arthroplasty
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-operativeProcedure or surgery
Also called Surgery Reverse Shoulder Arthroplasty
Non-operative treatment versus operative treatment (surgery)
| Study group | Role | What they receive |
|---|---|---|
| non operative treatment | No intervention | Proximal humeral fractures (PHF) treated non-operative, Rehabilitation only |
| Reverse Shoulder Arthroplasty (RSA) | Active comparator | RSA 135/ 155 inclination Receives: Procedure: Non-operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
All participants are assessed with online questionnaire, Patient Related Outcome Measurement (PROM) 0-100% (100% best), validated
Measured: one years follow up (FU)
Secondary outcomes (3)
Constant Murley score
All participants are assessed with function scores. 0-100% (100% best) by physiotherapist
Measured: one and two years FU
Subjective shoulder Volume (SSV)
All participants are assessed with online questionnaire PROM 0-100% (100% best)
Measured: one and two years FU
x-rays
stating healing, displacement, resorbtion of the tuberosities
Measured: one and two years FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Sep 2021
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
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 University of Southern DenmarkThe 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
- Model description
- RCT, single blinded
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Principal investigator, Klaus Wilhelm Josef Hanisch, University of Southern Denmark
- Investigators
- Klaus Hanisch, Study chair, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444828
- Sponsor's protocol ID
- ISRCTN85422168
- Status last verified
- Dec 2024
- First submitted
- 30 Nov 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Following Reverse Shoulder Arthroplasty for Acute Proximal Humerus Fractures in Patients 60 Years of Age and Older With Different Inclination Implants Versus Non-surgical Treatment- Trial Protocol: a Prospective RCT, Single Blinded
- ClinicalTrials.gov ID
- NCT06444828
- Acronym / sponsor ID
- ISRCTN85422168
- Conditions
- Proximal Humeral Fracture, Humeral Head Fracture
- Keywords
- proximal humerus fracture, Reverse Shoulder Arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Jun 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.
The optimal treatment of complex shoulder fracture is controversial. In general, non-surgical treatment is recommended for older patients, but results are often unsatisfying. Therefore different surgical approaches have been tried to improve outcomes for this group of patients. Reverse shoulder arthroplasty has shown promising results for these types of fractures and changes in the design of the implant might improve outcomes further. The aim of this study is to compare the outcomes of complex shoulder fractures after non-surgical versus surgical treatment and compare two different types of implants.
Detailed description
The optimal treatment of proximal humeral fracture (PHF) Neer type III and IV AO B1.1,1.2 and C1.1,3.1 is controversial. National guidelines for Denmark have been published in 2015 and updated 2019. They recommend conservative treatment to all kinds of PHF for patients aged above 60 years. Exceptions are fracture-dislocations, headsplits or surgical conditions, where intervention is mandatory like open fractures and impaired nerve- and circulation.
Recently reverse shoulder arthroplasty (RSA) has gained expanding popularity in treating PHF . Compared with osteosynthesis (ORIF) or hemiarthroplasty (HA) outcomes were superior , . The importance of tuberosity healing for good functional outcomes has lead to development of different implants and fixation techniques. The original RSA design by Grammont with 155 degree inclination of the humeral stem was made for cuff-arthropathy. This design moves the center of rotation in a medial direction, and increase the tension on the tuberosities.
In contrast "anatomical" designed humeral implants with 135 degree enables more anatomical refixation of the tuberosities with less tension and might reduce the risk of resorption or displacement of the fragments. To implant a 155 degree RSA the surgeon has to remove parts of the rotator cuff, to enable the sliding rotation. On the other hand with a 135 degree inclination humeral component, a cuff sparing technique is possible.
The aim of this study is to compare outcomes of two different designed RSA stems versus conservative treatment of PHF Neer type III or IV / AO B\&C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RCT, single blinded
| Arm | Type | Receives |
|---|---|---|
| non operative treatment | No intervention | –Proximal humeral fractures (PHF) treated non-operative, Rehabilitation only |
| Reverse Shoulder Arthroplasty (RSA) | Active comparator | Procedure: Non-operativeRSA 135/ 155 inclination |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Displaced Proximal Humeral Fractures (PHF) Neer type III or IV / AO B\&C. Radiological confirmed
Key exclusion criteria (1 listed)
- other types of PHF, Head splits, gleno-humeral dislocations, pathological fractures. Refuse to participate in the study. Non-compliant, drug/alcohol abuse or institutionalized, (Low-cooperative),
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 |
|---|---|---|
| Non-operativeAlso: Surgery Reverse Shoulder ArthroplastyNon-operative treatment versus operative treatment (surgery) | Procedure or surgery | Reverse Shoulder Arthroplasty (RSA) |
Primary outcome
The primary outcome is Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Time frame: one years follow up (FU)
All participants are assessed with online questionnaire, Patient Related Outcome Measurement (PROM) 0-100% (100% best), validated
3 secondary outcomes
Constant Murley score
Time frame: one and two years FU
Subjective shoulder Volume (SSV)
Time frame: one and two years FU
x-rays
Time frame: one and two years FU
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 11 Dec 2024.
- ISRCTNLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Proximal Humeral Fracture
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
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.
Klaus Hanisch study chair
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-operative in people with Proximal Humeral Fracture and Humeral Head Fracture, run by University of Southern Denmark at 1 site in Denmark.
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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 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 Denmark. 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?
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?
The primary outcome is Western Ontario Osteoarthritis of the Shoulder Index (WOOS) (time frame: one years follow up (FU)). 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 11 Dec 2024.