Trial document




This trial has been registered retrospectively.
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  DRKS00012654

Trial Description

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Title

Dynamometric and gait analysis of hip joint function in patients with underlying Metha® prosthesis and contralateral Bicontact® prosthesis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

When using artificial hip joints, the restoration of the original joint mechanics plays a crucial role in enabling the optimal functioning of the hip-surrounding musculature through the restoration of the muscular lever arms. The type of design and the position of the prosthesis socket used to the muscle function significantly affect it. The present study aims to compare the restoration of natural anatomy with two widely used stem implants. To measure forces, torques and muscle activities to objectify biomechanics, the methods of gait analysis and dynamometry can be used.

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Brief Summary in Scientific Language

In the implantation of total hip endoprostheses, the reconstruction of physiological joint biomechanics plays a decisive role in enabling the optimal functioning of the hip-surrounding musculature through the restoration of the muscular lever arms.
The reconstruction of the hip biomechanics refers on the one hand to the acetabulum component, whose position determines the center of rotation of the hip joint, and on the other hand to the stem component, whose geometry also has a significant influence on the restoration of functional anatomy (Ong 2012). With regard to the stem component, the terms of the so-called lateral and anterior offsets are of central importance, with which the muscular lever arms can be described in mediolateral and anteroposterior directions.
The present study focuses on the reconstruction of functional anatomy with the following different stem implants: the conventional straight stem prosthesis "Bicontact" and the short stem prosthesis "Metha".
For both types of prosthesis, the lateral offset can be influenced by the choice of different center-collum-diaphysis angles (CCD angles) of the prosthesis. The anterior offset, on the other hand, can be influenced in the Bicontact prosthesis by a rotation of the prosthesis (antetorsion), while the position of the Metha shaft results from the anatomical configuration of the femoral neck, which simulates the reconstruction of the anterior offset by tilting (antetilt) the shaft achieved ventrally (Budde 2016). A possible influence of these different mechanisms on joint function will be investigated in this study.
To measure forces, torques and muscle activities to objectify biomechanics, gait analysis and dynamometry methods can be used:
In the gait analysis, the ground reaction forces and torques are measured and evaluated by means of "marker tracking" and force measuring plates in order to detect possible problems in the gait pattern. However, these measurements are mainly used in dynamic movements, such as running or jumping.
With a dynamometer it is possible to differentiate the movement of different joints in different planes. In addition, it is possible to test different types of contraction, such as isometric (= contraction of muscles without movement) or isokinetic (= contraction of muscles with uniform joint movement). When using artificial hip joints, the restoration of the original joint mechanics plays a crucial role in enabling the optimal functioning of the hip-surrounding musculature through the restoration of the muscular lever arms. The type of design and the position of the prosthesis socket used to the muscle function significantly affect it. The present study aims to compare the restoration of natural anatomy with two widely used stem implants. To measure forces, torques and muscle activities to objectify biomechanics, the methods of gait analysis and dynamometry can be used.

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Organizational Data

  •   DRKS00012654
  •   2019/09/02
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  •   yes
  •   Approved
  •   7559, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   M16.9 -  Coxarthrosis, unspecified
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Interventions/Observational Groups

  •   In this study dynamometric and gait analytical investigations are carried out.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Other
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Primary Outcome

Evaluation of dynamometry for differences in maximum hip flexion / extension moments and hip abduction / adduction moments

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Secondary Outcome

-Evaluation of gait analysis in terms of differences in the endoprostheses
-Evaluation of the subjective evaluation of differences in the joint function of the inserted endoprostheses by the patients
-Evaluation of Clinical Scores (Harris Hip Score)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2018/01/08
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- At least 1 year postoperative course with existing hip replacement on both sides (on one side with Metha - and on the other side with Bicontact hip TEP)
- At least 2 years postoperative course after uncomplicated shaft change on Metha or Bicontact

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Exclusion Criteria

-Patient does not feel able to complete the investigation
-Not ambulatory patients

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Addresses

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    • Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift
    • Mr.  Dr.  Stefan  Budde 
    • Anna-von-Borries-Str. 1-7
    • 30625  Hannover
    • Germany
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    • Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift
    • Mr.  Dr.  Stefan  Budde 
    • Anna-von-Borries-Str. 1-7
    • 30625  Hannover
    • Germany
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    • Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift, Leitung Klinisches Studienmanagement
    • Ms.  Yvonne  Noll 
    • Anna-von-Borries-Str. 1-7
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Fa. Aeskulap AG
    • Am Aeskulap-Platz
    • 78532  Tuttlingen
    • Germany
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    •   07461-95-0
    •   17461-95-26-00
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Status

  •   Enrolling by invitation
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.