Proximal Humeral FracturesPhase 3NCT00835562
Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
A Phase 3 study testing Non-surgical management, Osteosynthesis and Hemiarthroplasty in people with Proximal Humeral Fractures, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Proximal Humeral Fractures
- What is being tested?
- Non-surgical management, Osteosynthesis and Hemiarthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2009to Mar 2013
- Phase
- Phase 3
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Displaced four-part fracture of the proximal humerus
- Mentally alert
- Physically fit for surgery and rehabilitation (ASA-group 1-3)
- Informed written consent
- Operation can be conducted within 2 weeks of injury
Who cannot join
- Fracture-dislocations
- Head-splitting fractures
- Previous shoulder surgery on injured side
- Chronic shoulder pain
- Abuse problems
- Patients unable to understand instructions in Danish
Trial locations and contacts
1 site in 1 country.
Stig Brorson, MD, PhD contact
Asbjørn Hrobjartsson, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Herlev University Hospital, Department Orthopaedic Surgery
Herlev, Denmark, DK-2730
Stig Brorson, MD, PhD, sbrorson@hotmail.com
Asbjørn Hrobjartsson, MD, PhD, ah@cochrane.dk
About this study
Official title: Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Displaced Four-part Fractures of the Proximal Humerus in Elderly: a Multi-centre, Randomised Clinical Trial
Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.
The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns.
The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.
- Conditions
- Proximal Humeral Fractures
- Being tested
- Non-surgical management, Osteosynthesis, Hemiarthroplasty
- Keywords
- Shoulder fractures, Proximal humeral fractures, Randomised clinical trial, elderly, Displaced four-part fractures of the proximal humerus
- 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-surgical managementProcedure or surgery
Non-surgical management (physiotherapy and self-training)
OsteosynthesisProcedure or surgery
Osteosynthesis with angle-stable plate followed by physiotherapy and self-training
HemiarthroplastyProcedure or surgery
Primary modular hemiarthroplasty followed by physiotherapy and self-training
| Study group | Role | What they receive |
|---|---|---|
| Osteosynthesis | Experimental | Not described Receives: Procedure: Osteosynthesis |
| Non-surgical | Experimental | Not described Receives: Procedure: Non-surgical management |
| Hemiarthroplasty | Experimental | Not described Receives: Procedure: Hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Disability Scale
Measured: 3 years
Secondary outcomes (1)
Oxford Shoulder Score, Short Form-36
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stig Brorson, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835562
- Sponsor's protocol ID
- Shoulderfractures.RCT
- Other IDs
- H-C-2008-065
- Status last verified
- Jun 2012
- First submitted
- 2 Feb 2009
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PubMed 35727196
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Displaced Four-part Fractures of the Proximal Humerus in Elderly: a Multi-centre, Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT00835562
- Acronym / sponsor ID
- Shoulderfractures.RCT
- Conditions
- Proximal Humeral Fractures
- Keywords
- Shoulder fractures, Proximal humeral fractures, Randomised clinical trial, elderly, Displaced four-part fractures of the proximal humerus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Zealand University Hospital, Odense University Hospital
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (estimated)
- First posted
- 3 Feb 2009 (estimated)
- 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.
Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.
The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns.
The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteosynthesis | Experimental | Procedure: Osteosynthesis |
| Non-surgical | Experimental | Procedure: Non-surgical management |
| Hemiarthroplasty | Experimental | Procedure: Hemiarthroplasty |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Displaced four-part fracture of the proximal humerus
- Mentally alert
- Physically fit for surgery and rehabilitation (ASA-group 1-3)
- Informed written consent
- Operation can be conducted within 2 weeks of injury
Key exclusion criteria (6 listed)
- Fracture-dislocations
- Head-splitting fractures
- Previous shoulder surgery on injured side
- Chronic shoulder pain
- Abuse problems
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-surgical managementNon-surgical management (physiotherapy and self-training) | Procedure or surgery | Non-surgical |
| OsteosynthesisOsteosynthesis with angle-stable plate followed by physiotherapy and self-training | Procedure or surgery | Osteosynthesis |
| HemiarthroplastyPrimary modular hemiarthroplasty followed by physiotherapy and self-training | Procedure or surgery | Hemiarthroplasty |
Primary outcome
Constant Disability Scale
Time frame: 3 years
1 secondary outcome
Oxford Shoulder Score, Short Form-36
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
- Derived from this study: PubMed 35727196Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
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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.
Stig Brorson, MD, PhD contact
Asbjørn Hrobjartsson, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Non-surgical management, Osteosynthesis and Hemiarthroplasty in people with Proximal Humeral Fractures, run by Herlev Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 7 Jun 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Stig Brorson, MD, PhD (sbrorson@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Disability Scale (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00835562, which also lists 1 linked publication.
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 7 Jun 2012.