Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00006180

Trial Description

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Title

Effect of Mulligan´s MWM-Technique to improve knee flexion in total knee replacement patients in the rehabilitation phase -
A randomized controlled trial

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In Germany annually about 150,000 total knee arthroplasty (TKA) surgeries are performed. To cope with their daily lives activities without any major limitations these patients require a sufficiently knee flexion of the operated joint. Evidence for a positive mobilization effect of manual therapy techniques, for example the Mobilization-With-Movement (MWM) technique of the Mulligan Concept, was published several times in the past. Since there are no published studies on the effect of therapeutic manual therapy techniques after TKA implantation at the time, no manual therapy techniques are found in the treatment standards of the payers for rehabilitation after knee replacement. The primary objective of this study was to investigate how the application of manual therapy technique MWM affected knee flexion improvement after primary total knee arthroplasty.

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Brief Summary in Scientific Language

Since there is no published evidence on the effect of MWM- techniques after TKA implantation at the time, the primary objective of this study was to investigate if the application of manual therapy technique MWM at the femorotibial-joint affected knee flexion improvement in the rehabilitation phase after primary total knee arthroplasty compared with a standard regime.

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Organizational Data

  •   DRKS00006180
  •   2016/03/09
  •   [---]*
  •   yes
  •   Approved
  •   2014 - 03, Ethikkommission an der Physio-Akademie des Deutschen Verbands für Physiotherapie
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Z96.6 -  Presence of orthopaedic joint implants
  •   Total knee replacement
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Interventions/Observational Groups

  •   Standard regimen for rehabilitative treatment after TKA ( total knee arthroplasty)
  •   Standard regimen for rehabilitative treatment after TKA inclusive Mulligans "Mobilization with movement" technique.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Knieflexion, measured by standard goniometer at the beginning and at the end of the outpatient rehabilitation

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Secondary Outcome

- Pain (messured with VAS)
- Funktion (messured with KOOS-Knee injury and Osteoarthritis Outcome Score -German version LK1.01)
- Knieextension (messured with standard goniometer).

Messured at the beginning and at the end of the outpatient rehabilitation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/01
  •   52
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   85   Years
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Additional Inclusion Criteria

- First time TKA
- Prothesis-Type: semi-/unconstrained
- 10.-60. postoperative day (intervention period)
- outpatient rehabilitation (multimodal-rehabilitation-concept)
- Age: 40-85
- sufficient knowledge of German

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Exclusion Criteria

- Replacement of the prosthesis
- Type of prosthesis: fully-constrained
- Patients with nerve damage in the lower limb
- Before the 10th postoperative day or after the 60th postoperative day (intervention period)
- Monomodal therapy Regulation
- Patients with thrombosis (DVT) or embolism
- Patients with Complex Regional Pain Syndrome (CPRS)
- Patients with ipsilateral arthritis of the hip / foot or highly painful hip / foot
- Ossifications in muscles
- Strong Arthrofibrosis
- Violent unexplained pain

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität des SaarlandesSchule für Physiotherapie
    • Mr.  M.Sc.  Deniz  Halil 
    • Kirrberger Str. 100
    • 66421  Homburg
    • Germany
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    • Universität des SaarlandesSchule für Physiotherapie
    • Mr.  M.Sc.  Deniz  Halil 
    • Kirrberger Str. 100
    • 66421  Homburg
    • Germany
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    • Universität des SaarlandesSchule für Physiotherapie
    • Mr.  M.Sc.  Deniz  Halil 
    • Kirrberger Str. 100
    • 66421  Homburg
    • Germany
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Sources of Monetary or Material Support

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    • maxQ. -im bfw- Schule für Physiotherapie Iserlohn
    • Mr.  Deniz  Halil 
    • Gennaer Str. 76
    • 58642  Iserlohn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/09/30
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Trial Publications, Results and other Documents

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