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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Munich University Hospital

    Munich, Bavaria, 80336

    Recruiting

Other trials in Germany

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).

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 groups in NCT02609906
Study groupRoleWhat they receive
PhilosTM with augmentation (Depuy-Synthes)OtherThe 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)OtherThe 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.

  1. Disabilities of the Shoulder, Arm and Hand-Score (DASH)

    Funcitonal outcome

    Measured: 24 months

Secondary outcomes (6)
  1. Constant Score (CS)

    Funcitonal outcome

    Measured: 24 months

  2. American Shoulder and Elbow Score (ASES)

    Funcitonal outcome

    Measured: 24 months

  3. Oxford Shoulder Score (OSS)

    Funcitonal outcome

    Measured: 24 months

  4. Range of motion (ROM)

    Funcitonal outcome

    Measured: 24 months

  5. Short Form 36 (SF-36)

    Life quality

    Measured: 24 months

  6. 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.

  1. First posted20 Nov 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2016 (estimated)

Resources

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)
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 19135560
  • Palvanen 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 16394745
  • Neer 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 5455339
  • 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
  • Helfen 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

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.

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