Trial document




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  DRKS00014798

Trial Description

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Title

power, proprioception and function after ACL with autograft: quadriceps vs. hamstrings

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to show how maximum power, speed power and jumping power of patients with an anterior cruciate ligament plastic develops after 3-5 years in comparison to the healthy leg. Those values are compared with the values aquired in the previous study. The main question is: do transplantation specific, muscular deficits of knee extensors and flexors continue to persist after 3-5 years?

Further questions are: Are there any functional deficits existing in comparison to the healthy leg? And if so, is there any correlation to the used tendons, the initial strength training or the regeneration of the muscle-power?

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Brief Summary in Scientific Language

This is a follow-up-study to a previous prospective and randomized study comparing ACL with hamstring and quadriceps tendon. Against expectations, the previous study showed that the strength deficit of the muscle used for the autograft was after six month still more severe than the tolerable rate of 1O% despite specific strength training. In this prospective, observant cohort study we examine the same patients again after 3-5 years. The main question is if the maximum strength deficits of the knee extensors or flexors persist. In addition we measure the speed with the ISOMED2000 and jumping power with a pressure measuring plat. The functional outcome is going to be quantified by 2-d videoanalysis of the drop jump, the active angle reproduction test, single leg hop test and triple leg hop test and the star excursion balance test. The subjective outcome is going to be measured with questionnaires: Tegner, Lysholm, IKDC, ACL RSI.

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Organizational Data

  •   DRKS00014798
  •   2018/06/19
  •   [---]*
  •   yes
  •   Approved
  •   S-176/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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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

  •   ACL with quadriceps autograft.

    We measure maximum power, speed power, jumping power of the knee flexors and extensors, knee function and coordination 3-5 years postoperative. These values are going to be compared with values of the previous study (3-6 month postoperative) and with the results of the patients, who received a semitendinosus ACL autograft.

  •   ACL with hamstring tendon autograft
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

primary outcome: relative maximum power of hamstrings and quadriceps with ISOMED2000

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Secondary Outcome

secondary outcome:
Power analysis: absolut maximum (60°/sec)power of hamstrings and quadriceps with ISOMED2000, absolut and relative speed power (180°/sec) of hamstrings and quadriceps with ISOMED 2000, Jumping power with pressure measuring platform

analysis of function and proprioception: 2-D Videoanalysis of drop jump with Landing error system scoring (LESS), Single leg hop and triple leg hop test, Star excursion balance test , angle reproduction test with ISOMED2000

questionnaires: Tegner, Lysholm, IKDC, ACL-RSI

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/06/18
  •   58
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

participation of the prior study with the intervention ACL with semitendinosus or quadriceps and additonally randomized allocation to isokinetic or conventional strength training

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Exclusion Criteria

acute knee- infection or knee- trauma or any other acute systemic infection

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Addresses

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    • Universität Heidelberg, Department für Orthopädie , Sektion Sportorthopädie
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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    • Olympia Stützpunkt Rhein-Neckar
    • Mr.  Dr.  Thomas  Gwechenberger 
    • INF 710
    • 69120  Heidelberg
    • Germany
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    • Department für Orthopädie, Sektionsleiter der Sportorthopädie der Uniklinik Heidelberg
    • Mr.  Dr.  Alexander  Barié 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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    • Universität Heidelberg, Department für Orthopädie, Sektion Sportorthopädie
    • Ms.  cand.med.  Judith  Sievers 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Department für Orthopädie, Bereich Sportorthopädie
    • Mr.  Dr.  Alexander  Barié 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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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.