Trial document




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  DRKS00015313

Trial Description

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Title

Effects of a home-based rehabilitation program on motor control, return to play, and recurrence rates after anterior cruciate ligament reconstruction: A randomized controlled trial

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Trial Acronym

PreP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of our study is to assess the effects and implementation capacity of the Stop-X-program after anterior cruciate ligament rupture and reconstruction on return-to-play (RTP)-associated function and recurrency prevention. The major aim is to compare the effects of a standard post-reconstruction rehabilitation plus standard follow-up care with the same basic care plus the Stop-X-follow-up care. Effects on RTP and motor control function, re-injury rates, and time to successfully RTP are the main outcomes to be assessed.

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Brief Summary in Scientific Language

The aim of the study is to assess the effects and implementation capacity of the Stop-X-program after anterior cruciate ligament rupture and reconstruction on return-to-play (RTP)-associated function and recurrency prevention. The major aim is to compare the effects of standardised evidence based rehabilitation plus standard follow-up care with the same evidence based care plus subsequent Stop-X-follow-up care. Effects on RTP and re-injury related motor control function re-injury rates, and time to successfully RTP are the main outcomes to be assessed.
H0: The Stop-X-Programm as a part of the evidence-based care and rehabilitation after anterior cruciate ligament rupture and reconstruction is not systematically superior to standard rehabilitation in terms of its effects on neuromuscular function, re-injury rate risk and time until RTP success.

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Organizational Data

  •   DRKS00015313
  •   2018/10/01
  •   [---]*
  •   yes
  •   Approved
  •   FF 104/2017, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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

  •   S83.53 -  [generalization S83.5: Sprain and strain involving (anterior)(posterior) cruciate ligament of knee]
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Interventions/Observational Groups

  •   Evidence-based rehabilitation and subsequent standard follow-up treatment
  •   Evidence-based rehabilitation and subsequent Stop-X-follow-up-treatment (http://deutsche-kniegesellschaft.de/wp-content/uploads/2017/02/DKG_Stop-X_Prävention-von-Sportverletzungen-am-Kniegelenk.pdf.)
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Characteristics

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

Normalized knee distance at landing and rective jumps during drop jumps (drop jum screening test). Knee valgus/varus position is rated at three pre-defined points during the drop jump cycle: initial ground contact at the end of the drop from the box – lowest point of the body's centre of gravity at the jump’s reversal point– ground take-off when the feet leave the surface for the reactive vertical jump. At each of this points, the distance between: 1. The two hip ankles and 2. The middles of the two knees are measured. A percentage amount of the knee distance in comparison to the hip distance was calculated to build the normalized knee distance.

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Secondary Outcome

1. Quality (subjective rating; knee angle, hip angle in sagizzal and frontal plane) during simple (combined) side and front jumps. 2. Questionnaire on return to sport after injury-ACL (RSI-ACL) assess participants’ fear/confidence on the reconstructed knee during their main sporting activity. 3. Time/date of consensur-evidence-based shared positive return to play decision. 4. one year folow-up subsequent ACL rupture.
Control variable will be Tegner/Lysholm-Score, IKDC-200, KOOS ADL, injury history, demografics, pain (VAS 10 cm), kinesiophobia (Tampa Scale of Kinesiophobia).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/10/15
  •   250
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   35   Years
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Additional Inclusion Criteria

Acute unilateral ACL rupture (positive pivot shift) and scheduled for subsequent arthroscopically applied, anatomic single bundle reconstruction.

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Exclusion Criteria

1. Meniscus lesion > 2 cm 2. Cartilage lesion > ICRS II° 3. previous musculoskeletal surgery of the uninvolved (contralateral) leg 4. leg mal-alignment > 5° 5. multiligament injury pattern 6. postoperative re-injury 7. acute or chronic inflammation of the musculoskeletal system or muscle soreness 8. non-compliance 9. Pregnancy

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Addresses

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    • Abteilung für Sportorthopädie, Knie- und SchulterchirurgieBGU – Frankfurt am Main
    • Mr.  PD Dr. Dr.  Thomas  Stein 
    • Friedberger Landstraße 430
    • 60389  Frankfurt
    • Germany
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    • Abteilung Sportmedizin, Goethe-Universität Frankfurt am Main
    • Mr.  Dr.  Daniel  Niederer 
    • Ginnheimer Landstraße 39
    • 60487  Frankfurt
    • Germany
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    • Abteilung Sportmedizin, Goethe-Universität Frankfurt am Main
    • Mr.  Dr.  Daniel  Niederer 
    • Ginnheimer Landstraße 39
    • 60487  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Abteilung für Sportorthopädie, Knie- und Schulterchirurgie BGU – Frankfurt am Main;Abteilung Sportmedizin, Goethe Universität Frankfurt
    • Mr. 
    • 60487  Frankfurt
    • Germany
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Status

  •   Recruiting ongoing
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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.