Trial document




drksid header

  DRKS00000719

Trial Description

start of 1:1-Block title

Title

Influence of musculature and prosthesis design
on tibiofemoral rotational stability after total knee arthroplasty

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

The knee arthroplasty belongs to one of the most common operations in the field of orthopedics. Although a normal walking feeling should be reached after this operations some patients complain about pain and insufficient knee stability. The aim of this study is to analyse the movement of the knee joint. Three different knee implants will be compared in order to summarize all the advantages with respect to the rotationstability. Many researchers have investigated the rotationstability of the knee using methods like X-rays images, navigation systems and gaitanalysis. But till now, it is not possible to perform an accurate measurement of the rotation of the knee joint over different knee flexion angles. A new method zur determination of the rotationstability of the knee joint would provide a clinic diagnostic tool to evaluate the differents implant options before the operation.

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

Brief Summary in Scientific Language

Stability has been cited to be one of the most important factors of successful TKA and axial rotation is important in TKA to achieve stability during flexion. Lack of stability may generate abnormal mechanical stress in the anatomic tissues potentially causing pain and also requires muscles and tendons to dynamically stabilized a knee that is not able to be statically stabilized
Muscle insufficiency is thought to lead to a reduction of rotational stability, but the relative contribution of the passive and active soft tissues remains unknown, moreover knee instability has been analysed mostly on the sagittal and not on the axial plane. As a result, the clinical selection of patients for CR, PS and Uni knee replacements is unclear. A method to quantify knee rotational stability would offer a clinical diagnosis tool for assessing patients pre-op for component selection. Furthermore, an assessment of rotational stability in revision cases could alude to the causes of pain and subsequent failure.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000719
  •   2011/02/15
  •   [---]*
  •   yes
  •   Approved
  •   EA1/232/10, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1119-4675 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M17.1 -  Other primary gonarthrosis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Unicondylar Endoprosthesis arthroplasty
  •   Cruciate retaining Totalendoprosthesis arthroplasty
  •   Cruciate sacrificing Totalendoprosthesis arthroplasty
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Analysis of the influence of the prosthesis design on the knee joint rotation stability in patients with 3 differente TKA implants with the use of gaitanalysis and fluoroscopie 3 and 12 months after operation

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

Secondary Outcome

no second outcome

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

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/08/16
  •   60
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Medial Ostearthritis Kellgren Grad III or IV, machanical leg axis between 0° and 10° varus, tibial slope between 0° and 10°, sufficient anterior and posterior cruciate ligaments confirmed after the clinical analysis without previous damages, stable collateral ligaments, an extension deficit smaller than 5°, an overextension smaller than 5°, healthy patella, BMI< 40, participation consent

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

Exclusion Criteria

Post-hoc, if after participation agreement the patient will not be operated.

Connective tissue diseases (Marfan sindrome, Ehlers-Danlos sindrome, Scleroderma)

Nervous system diseases (Parkinson, multiple sclerosis, Peripheral neuropathy)

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Julius Wolff Institut, Charité- Universitätsmedizin Berlin centrum für Sportwissenschaft und Sportmedizin Berlin
    • Mr.  Dr.  William   Taylor 
    • Philippstr. 13, Haus 11
    • 10099  Berlin
    • 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
    • Julius Wolff Institut, Charité- Universitätsmedizin Berlin centrum für Sportwissenschaft und Sportmedizin Berlin
    • Mr.  Dr.  William   Taylor 
    • Philippstr. 13, Haus 11
    • 10099  Berlin
    • 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
    • Julius Wolff Institut, Charité- Universittätsmedizin Berlin Centrum für Sportwissenschaft und Sportmedizin Berlin
    • Mr.  Dipl.- Ing.   Philippe  Moewis 
    • Philippstr. 13, Haus 11
    • 10099  Berlin
    • 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
    • European Commission Information Society and Media Directorate-General
    • Ms.  Karina  Marcus 
    • Commision européenne BU317 / 66
    • B-1049   Bruxellles
    • Belgium
    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 ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.