Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005590

Trial Description

start of 1:1-Block title

Title

Osteosynthesis of proximal humerus fractures: Carbon-Peek plate – a new interal fixation device.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Proximal humerus fractures may be treated operative or non-operative, depending on the fracture-pattern and patient specific factors. If an operative treatment is necessary and a preservation and reconstruction of the humeral head possible, typically a locking plate osteosynthesis made out of titanium-alloy has been used. Because of the development of new materials a locking plate osteosynthesis made out of carbon fiber-reinforced PEEK is provided. The benefits shall be a higher stability and less scarring along the plate. Both materials are already applied in clinical practice, but up to date it has not been analysed, which material is more beneficial for the patient.

The Department of Traumatology of the Friederikenstift Hannover is performing a follow-up examination on patients with proximal humerus fractures who received a carbon PEEK osteosynthesis, to gain further information about pros and cons. The follow-up examination is taking place after 3 and 12 months.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Proximal humerus fractures with dislocation may be treated – depending on the operation indication – with open reduction an internal fixation through locking plate osteosynthesis. New material developments enable the use of carbon-PEEK plate osteosynthesis besides the conventional osteosynthesis made out of steel (for example Philos plate). But, clinical results of this novel osteosynthesis are not yet available.

Therefore the Department of Traumatology of the Friederikenstift Hannover is performing a prospective follow-up examination on patients with proximal humerus fractures who received a carbon PEEK osteosynthesis, to gain further information about pros and cons. The follow-up examination is taking place after 3 and 12 months.

Information about patient satisfaction und pain is collected. The active and passive range of motion measures the functional outcome of the shoulder. Subjective and objective shoulder scores (CS, SSS, SSV) are evaluated, complications analysed and revision operations registered. Therefore besides the patient survey a clinical examination and evaluation of the patient’s medical history is performed and pre- and post-operative x-rays are analysed. The overall number of cases will be up to 40 patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005590
  •   2014/01/10
  •   [---]*
  •   yes
  •   Approved
  •   2015-2013, Ethikkommission der Medizinischen Hochschule Hannover
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   S42.20 -  [generalization S42.2: Fracture of upper end of humerus]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Clinical results after operative treatment of a proximal humerus fracture with carbon-PEEK plate osteosynthesis:

    The Department of Traumatology of the Friederikenstift Hannover is performing a prospective follow-up examination on patients with proximal humerus fractures who received a carbon PEEK osteosynthesis. The follow-up examination is taking place after 3 and 12 months.

    Information about patient satisfaction und pain is collected. The active and passive range of motion measures the functional outcome of the shoulder. Subjective and objective shoulder scores (CS, SSS, SSV) are evaluated, complications analysed and revision operations registered. Therefore besides the patient survey a clinical examination and evaluation of the patient’s medical history is performed and pre- and post-operative x-rays are analysed.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

After 3 months: evaluation of short-term results based on therapy failure, complications and clinical result. Therefore a postoperative patient history, clinical examination, Constant-Score, age corrected Constant-Score, Simple-Shoulder-Score and Subjective Shoulder Value are required.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

After 12 months: evaluation of mid-term results based on therapy failure, complications and clinical result. Therefore a postoperative patient history, clinical examination, Constant-Score, age corrected Constant-Score, Simple-Shoulder-Score and Subjective Shoulder Value are required.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/10/18
  •   40
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Indication for surgery of a proximal humerus fracture and internal fixation with a carbon-PEEK osteosynthesis, sufficient patient compliance, existence of a signed study consent form after oral and written education.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Preexisting injuries, which affect motion or strength of the shoulder, pre-operation of the affected shoulder, a immunsuppressive therapy, drug or alcohol abuse, legal incompetence or missing study consent form.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Friederikenstift Hannover, Abteilung Unfall- und Wiederherstellungschirurgie
    • Mr.  Prof. Dr.  Helmut  Lill 
    • Humboldtstr. 5
    • 30169  Hannover
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Friederikenstift Hannover, Abteilung Unfall- und Wiederherstellungschirurgie
    • Mr.  Dr.  Christoph  Katthagen 
    • Humboldtstr. 5
    • 30169  Hannover
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Friederikenstift Hannover, Abteilung Unfall- und Wiederherstellungschirurgie
    • Mr.  Dr.  Christoph  Katthagen 
    • Humboldtstr. 5
    • 30169  Hannover
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Friederikenstift Hannover, Abteilung Unfall- und Wiederherstellungschirurgie
    • Mr.  Prof. Dr.  Helmut  Lill 
    • Humboldtstr. 5
    • 30169  Hannover
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/09/30
end of 1:1-Block state
* This entry means the parameter is not applicable or has not been set.