Shoulder FracturesNCT02609906
Operative Treatment of 2-fragment-fractures (AO 11-A3) of the Proximal Humerus in the Elderly: Cement Augmented Locking Plate Philos vs. Proximal Humerus Nail MultiLoc
A study testing PhilosTM with augmentation (Depuy-Synthes) and MultiLoc®-Nail (Depuy-Synthes) in people with Shoulder Fractures and Intramedullary, run by LMU Klinikum at 1 site in Germany.
Trial summary
Proximal humeral fractures are with an incidence of 4-5% the third most common fractures in the elderly. Compared to fractures of the upper limb it is the second most common fracture after distal radial fractures. 65% of all patients with a proximal humeral fracture are older than 60 years. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Fractures, Intramedullary, Bone Plates
- What is being tested?
- PhilosTM with augmentation (Depuy-Synthes) and MultiLoc®-Nail (Depuy-Synthes)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Nov 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≤60 years or younger postmenopausal woman
- 2-fragment-fracture according to AO-classification AO 11-A3
- Signed informed consent
- Patient can read and understand German
Who cannot join
- Refusal to participate in the study
- Not Independent
- Dementia and/or institutionalized
- Does not understand written and spoken guidance German
- Pathologic fracture or a previous fracture of the same proximal humerus
- Alcoholism or drug addiction, e.g., in the emergency department, breathalyzer indicates blood alcohol concentration of more than 2%
Show all 17Show fewer
- Other injury to the same upper limb requiring surgery
- Major nerve injury (e.g., complete radial- or axillary nerve palsy)
- Rotator cuff tear arthropathy
- Open fracture
- Multi-trauma or -fractured patient
- Fracture dislocation or head-splitting fracture
- Non-displaced fracture
- Isolated fracture of the major or minor tubercle
- Gross displacement of the fracture fragments (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface)
- Any medical condition that excludes surgical treatment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Munich University Hospital
Munich, Bavaria, 80336
About this study
Proximal humeral fractures are with an incidence of 4-5% the third most common fractures in the elderly. Compared to fractures of the upper limb it is the second most common fracture after distal radial fractures. 65% of all patients with a proximal humeral fracture are older than 60 years. Being aware of the demographic change there will even be an increase of incidence of these fractures. Kannus et al. showed an incidence of 298 per 100,000 in the at least 80 years old patients in 2007. Palvanen et al. predict an increase of incidence of 50% until 2030.
Approximately 80% of all humeral fractures are minimally or non-displaced and can be treated conservatively with a good functional result. In 20% of humeral fractures there is an indication for surgical treatment according to the modified Neer-Criteria. These criteria are fulfilled if there is an angulation of at least 45 degrees between fracture fragments, a displacement of the humeral shaft against the humeral head of at least 1 cm or a dislocation of the tuberculum of at least 5 mm.
Read more
Up to now there is evidence for superiority of any surgical treatment in literature. At the moment the most frequently used surgical technique for treatment of proximal humeral fractures is the angle stable plate fixation. There are various publications concerning this topic published by the investigators research group. In their 10-years results a majority of patients showed excellent and good, but also 16% showed unsatisfactory results after locking plate fixation. Main risk for poor outcome was revision surgery caused by secondary displacement (14%) which is also confirmed by results of other studies. In a further study investigators could show that there is a higher risk for secondary displacement in 2-part-fractures with a gross primary dislocation or a large metaphyseal fracture zone (AO 11-A3), especially in osteoporotic patients. More over these are common fractures and because of that a problem in surgical treatment.
A secondary varus dislocation of the head fragment and cutting-out are the most common complications of angle stable locking plates in AO 11-A3 fractures of the elderly. The primary reason for this mechanism of failure is certain instability of transmetaphyseal fractures in the region of the surgical neck caused by loss of impaction in a porous spongiosa. Because of that the forces on the head screws are high while the so called screw-bone-interface is rather weak after a surgical treatment.
Currently there exist various approaches to avoid a failure of the primary screw implantation. One possibility to increase the stability of the screw-bone-interface is the cement augmentation of the screw tips. To date there exist no clinical study that reports the results of locking plate fixation and the augmentation of cannulated head screws although it is a widely used method in everyday surgery, especially in the elderly.
A second possibility to prevent secondary displacement after surgical treatment of 2-fragment-fractures is the use of an intramedullary nails. A further development of intramedullary nails is multiplanar nailing. Screws can be inserted in various different levels and directions which can lead to a clearly higher stability.
A comparison of these two treatment options augmented locking plate versus multiplanar angle stable locking nail in 2-part proximal humeral fractures has not been carried out up to now.
Read the detailed description
Because of the lack of clinical studies which compare cement augmented locking plates with multiplanar humeral nail systems after 2-part proximal humeral fractures, the decision of surgical method currently depends only on surgeons favour. Because only a randomized clinical trial (RCT) can sufficiently answer the question if one treatment option provides advantages compared to the other method we are planning to perform a RCT.
Investigators hypothesis: The cement augmented angle stable plate fixation system PhilosTM with augmentation (Depuy-Synthes) achieves significant differences concerning intra- and postoperative complication and revision rate, functional outcome and patient satisfaction compared to the multiplanar proximal MultiLoc®-Nail (Depuy-Synthes) in terms of Disabilities of the Shoulder, Arm and Hand-Score (DASH) Constant Score (CS), American Shoulder and Elbow Score (ASES), Oxford Shoulder Score (OSS), Range of motion (ROM) and Short Form 36 (SF-36).
- Conditions
- Shoulder Fractures, Intramedullary, Bone Plates
- Being tested
- PhilosTM with augmentation (Depuy-Synthes), MultiLoc®-Nail (Depuy-Synthes)
- Keywords
- proximal humerus, AO 11-A3 fracture, MultiLoc, Philos augmented
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhilosTM with augmentation (Depuy-Synthes)Device
All fractures will initially be immobilised by a Gilchrist-bandage. This is the same procedure as for patients who do not attend this or any other trial and will be performed by the doctor on-duty in the emergency room. Patients will be admitted to the trauma ward after that. On the same day or at the latest on day after this patients will be informed about the current investigation, screened, included and randomized by one of the study doctors to our trial after written consent will be obtained as described above.
Operative treatment is exclusively performed by the below mentioned study doctors. This group will be treated by the angle stable plate fixation system PhilosTM with augmentation (Depuy-Synthes).
MultiLoc®-Nail (Depuy-Synthes)Device
All fractures will initially be immobilised by a Gilchrist-bandage. This is the same procedure as for patients who do not attend this or any other trial and will be performed by the doctor on-duty in the emergency room. Patients will be admitted to the trauma ward after that. On the same day or at the latest on day after this patients will be informed about the current investigation, screened, included and randomized by one of the study doctors to our trial after written consent will be obtained as described above.
Operative treatment is exclusively performed by the below mentioned study doctors. This group will be treated by the multiplanar proximal humeral nail MultiLoc® (Depuy-Synthes).
| Study group | Role | What they receive |
|---|---|---|
| PhilosTM with augmentation (Depuy-Synthes) | Other | The intervention group will be treated by the angle stable plate fixation system PhilosTM with augmentation (Depuy-Synthes) Receives: Device: MultiLoc®-Nail (Depuy-Synthes) |
| MultiLoc®-Nail (Depuy-Synthes) | Other | The comparison group will be treated by the multiplanar proximal humeral nail MultiLoc® (Depuy-Synthes). Receives: Device: PhilosTM with augmentation (Depuy-Synthes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Shoulder, Arm and Hand-Score (DASH)
Funcitonal outcome
Measured: 24 months
Secondary outcomes (6)
Constant Score (CS)
Funcitonal outcome
Measured: 24 months
American Shoulder and Elbow Score (ASES)
Funcitonal outcome
Measured: 24 months
Oxford Shoulder Score (OSS)
Funcitonal outcome
Measured: 24 months
Range of motion (ROM)
Funcitonal outcome
Measured: 24 months
Short Form 36 (SF-36)
Life quality
Measured: 24 months
Barthel Index
Life quality
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Helfen, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609906
- Sponsor's protocol ID
- 510-15
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kannus P, Palvanen M, Niemi S, Sievanen H, Parkkari J. Rate of proximal humeral fractures in older Finnish women between 1970 and 2007. Bone. 2009 Apr;44(4):656-9. doi: 10.1016/j.bone.2008.12.007. Epub 2008 Dec 24.
PubMed 19135560Palvanen M, Kannus P, Niemi S, Parkkari J. Update in the epidemiology of proximal humeral fractures. Clin Orthop Relat Res. 2006 Jan;442:87-92. doi: 10.1097/01.blo.0000194672.79634.78.
PubMed 16394745Neer CS 2nd. Displaced proximal humeral fractures. I. Classification and evaluation. J Bone Joint Surg Am. 1970 Sep;52(6):1077-89. No abstract available.
PubMed 5455339Handoll 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 35727196Helfen T, Siebenburger G, Mayer M, Bocker W, Ockert B, Haasters F. Operative treatment of 2-part surgical neck fractures of the proximal humerus (AO 11-A3) in the elderly: Cement augmented locking plate Philos vs. proximal humerus nail MultiLoc(R). BMC Musculoskelet Disord. 2016 Oct 28;17(1):448. doi: 10.1186/s12891-016-1302-6.
PubMed 27793135
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Treatment of 2-fragment-fractures (AO 11-A3) of the Proximal Humerus in the Elderly: Cement Augmented Locking Plate Philos vs. Proximal Humerus Nail MultiLoc
- ClinicalTrials.gov ID
- NCT02609906
- Acronym / sponsor ID
- 510-15
- Conditions
- Shoulder Fractures, Intramedullary, Bone Plates
- Keywords
- proximal humerus, AO 11-A3 fracture, MultiLoc, Philos augmented
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- First posted
- 20 Nov 2015 (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.
Proximal humeral fractures are with an incidence of 4-5% the third most common fractures in the elderly. Compared to fractures of the upper limb it is the second most common fracture after distal radial fractures. 65% of all patients with a proximal humeral fracture are older than 60 years. Being aware of the demographic change there will even be an increase of incidence of these fractures. Kannus et al. showed an incidence of 298 per 100,000 in the at least 80 years old patients in 2007. Palvanen et al. predict an increase of incidence of 50% until 2030.
Approximately 80% of all humeral fractures are minimally or non-displaced and can be treated conservatively with a good functional result. In 20% of humeral fractures there is an indication for surgical treatment according to the modified Neer-Criteria. These criteria are fulfilled if there is an angulation of at least 45 degrees between fracture fragments, a displacement of the humeral shaft against the humeral head of at least 1 cm or a dislocation of the tuberculum of at least 5 mm.
Up to now there is evidence for superiority of any surgical treatment in literature. At the moment the most frequently used surgical technique for treatment of proximal humeral fractures is the angle stable plate fixation. There are various publications concerning this topic published by the investigators research group. In their 10-years results a majority of patients showed excellent and good, but also 16% showed unsatisfactory results after locking plate fixation. Main risk for poor outcome was revision surgery caused by secondary displacement (14%) which is also confirmed by results of other studies. In a further study investigators could show that there is a higher risk for secondary displacement in 2-part-fractures with a gross primary dislocation or a large metaphyseal fracture zone (AO 11-A3), especially in osteoporotic patients. More over these are common fractures and because of that a problem in surgical treatment.
A secondary varus dislocation of the head fragment and cutting-out are the most common complications of angle stable locking plates in AO 11-A3 fractures of the elderly. The primary reason for this mechanism of failure is certain instability of transmetaphyseal fractures in the region of the surgical neck caused by loss of impaction in a porous spongiosa. Because of that the forces on the head screws are high while the so called screw-bone-interface is rather weak after a surgical treatment.
Currently there exist various approaches to avoid a failure of the primary screw implantation. One possibility to increase the stability of the screw-bone-interface is the cement augmentation of the screw tips. To date there exist no clinical study that reports the results of locking plate fixation and the augmentation of cannulated head screws although it is a widely used method in everyday surgery, especially in the elderly.
A second possibility to prevent secondary displacement after surgical treatment of 2-fragment-fractures is the use of an intramedullary nails. A further development of intramedullary nails is multiplanar nailing. Screws can be inserted in various different levels and directions which can lead to a clearly higher stability.
A comparison of these two treatment options augmented locking plate versus multiplanar angle stable locking nail in 2-part proximal humeral fractures has not been carried out up to now.
Detailed description
Because of the lack of clinical studies which compare cement augmented locking plates with multiplanar humeral nail systems after 2-part proximal humeral fractures, the decision of surgical method currently depends only on surgeons favour. Because only a randomized clinical trial (RCT) can sufficiently answer the question if one treatment option provides advantages compared to the other method we are planning to perform a RCT.
Investigators hypothesis: The cement augmented angle stable plate fixation system PhilosTM with augmentation (Depuy-Synthes) achieves significant differences concerning intra- and postoperative complication and revision rate, functional outcome and patient satisfaction compared to the multiplanar proximal MultiLoc®-Nail (Depuy-Synthes) in terms of Disabilities of the Shoulder, Arm and Hand-Score (DASH) Constant Score (CS), American Shoulder and Elbow Score (ASES), Oxford Shoulder Score (OSS), Range of motion (ROM) and Short Form 36 (SF-36).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PhilosTM with augmentation (Depuy-Synthes) | Other | Device: MultiLoc®-Nail (Depuy-Synthes)The intervention group will be treated by the angle stable plate fixation system PhilosTM with augmentation (Depuy-Synthes) |
| MultiLoc®-Nail (Depuy-Synthes) | Other | Device: PhilosTM with augmentation (Depuy-Synthes)The comparison group will be treated by the multiplanar proximal humeral nail MultiLoc® (Depuy-Synthes). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≤60 years or younger postmenopausal woman
- 2-fragment-fracture according to AO-classification AO 11-A3
- Signed informed consent
- Patient can read and understand German
Key exclusion criteria (17 listed)
- Refusal to participate in the study
- Not Independent
- Dementia and/or institutionalized
- Does not understand written and spoken guidance German
- Pathologic fracture or a previous fracture of the same proximal humerus
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 |
|---|---|---|
| PhilosTM with augmentation (Depuy-Synthes)All fractures will initially be immobilised by a Gilchrist-bandage. This is the same procedure as for patients who do not attend this or any other trial and will be performed by the doctor on-duty in the emergency room. Patients will be admitted to the trauma ward after that. On the same day or at the latest on day after this patients will be informed about the current investigation, screened, included and randomized by one of the study doctors to our trial after written consent will be obtained as described above. Operative treatment is exclusively performed by the below mentioned study doctors. This group will be treated by the angle stable plate fixation system PhilosTM with augmentation (Depuy-Synthes). | Device | MultiLoc®-Nail (Depuy-Synthes) |
| MultiLoc®-Nail (Depuy-Synthes)All fractures will initially be immobilised by a Gilchrist-bandage. This is the same procedure as for patients who do not attend this or any other trial and will be performed by the doctor on-duty in the emergency room. Patients will be admitted to the trauma ward after that. On the same day or at the latest on day after this patients will be informed about the current investigation, screened, included and randomized by one of the study doctors to our trial after written consent will be obtained as described above. Operative treatment is exclusively performed by the below mentioned study doctors. This group will be treated by the multiplanar proximal humeral nail MultiLoc® (Depuy-Synthes). | Device | PhilosTM with augmentation (Depuy-Synthes) |
Primary outcome
Disabilities of the Shoulder, Arm and Hand-Score (DASH)
Time frame: 24 months
Funcitonal outcome
6 secondary outcomes
Constant Score (CS)
Time frame: 24 months
American Shoulder and Elbow Score (ASES)
Time frame: 24 months
Oxford Shoulder Score (OSS)
Time frame: 24 months
Range of motion (ROM)
Time frame: 24 months
Short Form 36 (SF-36)
Time frame: 24 months
Barthel Index
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Results publication: PubMed 19135560Kannus P, Palvanen M, Niemi S, Sievanen H, Parkkari J. Rate of proximal humeral fractures in older Finnish women between 1970 and 2007. Bone. 2009 Apr;44(4):656-9. doi: 10.1016/j.bone.2008.12.007. Epub 2008 Dec 24.
- Results publication: PubMed 16394745Palvanen M, Kannus P, Niemi S, Parkkari J. Update in the epidemiology of proximal humeral fractures. Clin Orthop Relat Res. 2006 Jan;442:87-92. doi: 10.1097/01.blo.0000194672.79634.78.
- Results publication: PubMed 5455339Neer CS 2nd. Displaced proximal humeral fractures. I. Classification and evaluation. J Bone Joint Surg Am. 1970 Sep;52(6):1077-89. No abstract available.
- 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.
- Derived from this study: PubMed 27793135Helfen T, Siebenburger G, Mayer M, Bocker W, Ockert B, Haasters F. Operative treatment of 2-part surgical neck fractures of the proximal humerus (AO 11-A3) in the elderly: Cement augmented locking plate Philos vs. proximal humerus nail MultiLoc(R). BMC Musculoskelet Disord. 2016 Oct 28;17(1):448. doi: 10.1186/s12891-016-1302-6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PhilosTM with augmentation (Depuy-Synthes) and MultiLoc®-Nail (Depuy-Synthes) in people with Shoulder Fractures and Intramedullary, run by LMU Klinikum at 1 site in Germany.
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 4 inclusion and 17 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 20 Nov 2015. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Helfen, MD (004989440052511, tobias.helfen@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Shoulder, Arm and Hand-Score (DASH) (time frame: 24 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 NCT02609906, which also lists 5 linked publications.
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 20 Nov 2015.