Proximal Humerus FracturesHUMERUSNCT01557413
Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures
A study testing Intramedullary nail and Locked plate in people with Proximal Humerus Fractures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Primary purpose of this study was to compare functional outcomes after displaced and proximal humerus fracture between nails and locked plates. The hypothesis is that intramedullary nails provides satisfactory fixation and functional outcome compared to locked plate. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Proximal Humerus Fractures
- What is being tested?
- Intramedullary nail and Locked plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Dec 2016
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between 40 and 85-years-old, who didn't expressed opposition to inclusion, with type III or IV displaced CEPHALOTUBEROSITY fracture( classification of Neer and DUPARC).
Who cannot join
- CEPHALOTUBEROSITY fractures type IV - CT4 will not be included because it can correspond to posterior or anterior fracture-dislocation of humeral head and therefore be associated to very high risk level of avascular necrosis . In this case a surgical treatment by arthroplasty is recommended.
- Dislocated fracture Patient who express opposition to inclusion polytrauma
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard
Paris, Île-de-France Region, 75018
About this study
Official title: Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures in Patients After 40-year-old
Primary purpose of this study was to compare functional outcomes after displaced and proximal humerus fracture between nails and locked plates.
The hypothesis is that intramedullary nails provides satisfactory fixation and functional outcome compared to locked plate.
Read the detailed description
: Proximal humerus fractures have a higher occurrence in elderly patients and therefore represent a public health problem.
Prognosis depends on greater and lesser tuberosity status, where rotator tendons of the shoulder have their insertion site.
Surgical treatment is recommended in case of tuberosities displacement. Goals are their anatomic reduction and stable primary fixation that will allow good bone healing and early mobilization. It has been demonstrated that an extended immobilization can result in stiffness by capsular retraction. On the contrary a too early mobilization can lead to secondary displacement of tuberosities and malunion.
These sequelae can be responsible for real disability when occuring in active patients, in particular when dominant limb is affected.
Internal fixation by locking intramedullary nails is currently the first choice technique because less invasive. However it doesn't always provide a good bone fixation, leading to tuberosities displacement or longer immobilization that decrease shoulder function prognosis. Locking plates represent a good alternative to avoid these complications by offering a better fixation of tuberosities in osteoporotic bone.
Though there is no existing randomised study comparing these techniques regarding functional outcomes, complications rates, and patient satisfaction.
- Conditions
- Proximal Humerus Fractures
- Being tested
- Intramedullary nail, Locked plate
- Keywords
- Humerus, fracture, nail, plate, tuberosity
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary nailProcedure or surgery
Also called SURFIX, Integra
the fracture was reduced and fix by an intramedullary humeral nail (Multilock, SYNTHES, Switzerland) using an open surgery. An anterolateral approach will be performed, the patient sit in beach chair position under general anesthesia. If required additional sutures will be authorized to fix the tuberosities.
Locked plateProcedure or surgery
Also called Multilock, SYNTHES
the fracture was reduced and fix by a locking plate using an open surgery (SURFIX, Integra, France). A deltopectoral approach will be performed, the patient sit in beach position under general anesthesia. If required, additional sutures will be authorized to fix the tuberosities.
| Study group | Role | What they receive |
|---|---|---|
| Intramedullary nail | Experimental | Intramedullary nail Receives: Procedure: Intramedullary nail |
| Locked plate | Experimental | Locked plate Receives: Procedure: Locked plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant and MURLEY Score
comparison of shoulder function outcome between 2 groups using Constant- Murley score after 12 months( mobility, function, pain and strength)
Measured: 12 months
Secondary outcomes (1)
Quick Dash, complication (mal union, necrosis, infection)
comparison of Constant-Murley score after 6 and 18 months, comparison of complications rates and patients satisfaction( DASH and STT scores).
Those criteriae will be analysed on global groups and for each Neer and Duparc classification type fracture.
Measured: 6 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2016
- Study completionDec 2016
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 Humerus FracturesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Boyer, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557413
- Sponsor's protocol ID
- AOO269-32
- Acronym
- HUMERUS
- Status last verified
- Feb 2017
- First submitted
- 16 Mar 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures in Patients After 40-year-old
- ClinicalTrials.gov ID
- NCT01557413
- Acronym / sponsor ID
- HUMERUS / AOO269-32
- Conditions
- Proximal Humerus Fractures
- Keywords
- Humerus, fracture, nail, plate, tuberosity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Mar 2012 (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.
Primary purpose of this study was to compare functional outcomes after displaced and proximal humerus fracture between nails and locked plates.
The hypothesis is that intramedullary nails provides satisfactory fixation and functional outcome compared to locked plate.
Detailed description
: Proximal humerus fractures have a higher occurrence in elderly patients and therefore represent a public health problem.
Prognosis depends on greater and lesser tuberosity status, where rotator tendons of the shoulder have their insertion site.
Surgical treatment is recommended in case of tuberosities displacement. Goals are their anatomic reduction and stable primary fixation that will allow good bone healing and early mobilization. It has been demonstrated that an extended immobilization can result in stiffness by capsular retraction. On the contrary a too early mobilization can lead to secondary displacement of tuberosities and malunion.
These sequelae can be responsible for real disability when occuring in active patients, in particular when dominant limb is affected.
Internal fixation by locking intramedullary nails is currently the first choice technique because less invasive. However it doesn't always provide a good bone fixation, leading to tuberosities displacement or longer immobilization that decrease shoulder function prognosis. Locking plates represent a good alternative to avoid these complications by offering a better fixation of tuberosities in osteoporotic bone.
Though there is no existing randomised study comparing these techniques regarding functional outcomes, complications rates, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramedullary nail | Experimental | Procedure: Intramedullary nailIntramedullary nail |
| Locked plate | Experimental | Procedure: Locked plateLocked plate |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients between 40 and 85-years-old, who didn't expressed opposition to inclusion, with type III or IV displaced CEPHALOTUBEROSITY fracture( classification of Neer and DUPARC).
Key exclusion criteria (2 listed)
- CEPHALOTUBEROSITY fractures type IV - CT4 will not be included because it can correspond to posterior or anterior fracture-dislocation of humeral head and therefore be associated to very high risk level of avascular necrosis . In this case a surgical treatment by arthroplasty is recommended.
- Dislocated fracture Patient who express opposition to inclusion polytrauma
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 |
|---|---|---|
| Intramedullary nailAlso: SURFIX, Integrathe fracture was reduced and fix by an intramedullary humeral nail (Multilock, SYNTHES, Switzerland) using an open surgery. An anterolateral approach will be performed, the patient sit in beach chair position under general anesthesia. If required additional sutures will be authorized to fix the tuberosities. | Procedure or surgery | Intramedullary nail |
| Locked plateAlso: Multilock, SYNTHESthe fracture was reduced and fix by a locking plate using an open surgery (SURFIX, Integra, France). A deltopectoral approach will be performed, the patient sit in beach position under general anesthesia. If required, additional sutures will be authorized to fix the tuberosities. | Procedure or surgery | Locked plate |
Primary outcome
Constant and MURLEY Score
Time frame: 12 months
comparison of shoulder function outcome between 2 groups using Constant- Murley score after 12 months( mobility, function, pain and strength)
1 secondary outcome
Quick Dash, complication (mal union, necrosis, infection)
Time frame: 6 and 18 months
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 23 Feb 2017.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Patrick Boyer, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramedullary nail and Locked plate in people with Proximal Humerus Fractures, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 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 23 Feb 2017. 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 France. 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?
Constant and MURLEY Score (time frame: 12 months). 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 NCT01557413, 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 23 Feb 2017.