Trial document





This trial has been registered retrospectively.
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  DRKS00013059

Trial Description

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Title

Does primary single suture anchor refixation of anterior cruciate ligament proximal avulsion tears lead to good functional long-term results- a case series of 12 patients

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study was to evaluate long-term results after suture repair of ruptured anterior cruciate ligaments. Therefore, a clinical
examination including scores to measure knee dependend impairment of daily living and sports acitivies is planned. The investigation takes place with a minimum time lag of five years from the operation.

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Brief Summary in Scientific Language

Current studies demonstrate encouraging short-term results after primary anterior cruciate ligament (ACL) suture anchor repair. However, earlier studies reported deterioration of knee function at five-year follow-up following good clinical short-term recovery. Therefore, the aim of this study was to evaluate clinical long-term results after primary ACL repair at a minimum five-year follow-up.
In a review, 12 patients were included who had been operated between 2009 and 2012. Inclusion criteria were an acute proximal, femoral avulsion tear of the ACL with good tissue quality and sagittal instability in a healthy, demanding patient. Patients suffering proximal tibial fractures, arthrosis or multiligamentous injuries of the knee were excluded. The ACL was anchored to the footprint by a single 2.9 mm PushLock anchor, followed by additional microfracturing. For follow up, Patients were evaluated according to Lysholm score, modified Cincinnati score, and Tegner activity score. Clinical examination was performed using Lachmann and pivot shift testing, range of motion and sagittal stability measurement using a Rolimeter.

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Organizational Data

  •   DRKS00013059
  •   2017/10/24
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   2016-095, Ethik-Kommission der Bayerischen Landesärztekammer
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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

  •   Clinical examination of knee function, knee stability and knee dependend life Quality via Scores of patients who were treated operatively with single suture anchor repair of proximal ACL avulsion tears with a Minimum follow up of 5 years
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

knee function in clinical Investigation, knee depending life Quality measured with scores (Cincinatti Score, Tegner Activity Score, Lysholm Score, IKDC-Score), knee stability measured with rolimeter

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/07/11
  •   13
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

acute proximal avulsion tear of the anterior cruciate Ligament (ACL) with sagittal instability, single suture anchor refixation of the ACL (at least 5 years ago) in patients with sporting demand for knee function

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Exclusion Criteria

multiligamentorous injuries of the knee, proximal tibial fractures, concomitand Injuries of the contralateral knee

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Addresses

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    • Klinikum Garmisch-Partenkirchen
    • Mr.  Dr. med.  Christof  Hoffmann 
    • Auenstraße 6
    • 82467  Garmisch-Partenkirchen
    • Germany
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    • Klinikum Garmisch-Partenkirchen, Abt. Unfallchirurgie und Sportorthopädie
    • Mr.  Dr. med.  Christof  Hoffmann 
    • Auenstrasse 6
    • 82467  Garmisch-Partenkirchen
    • Germany
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    • Klinikum Garmisch-Partenkirchen, Abt. Unfallchirurgie und Sportorthopädie
    • Mr.  Dr. med.  Christof  Hoffmann 
    • Auenstrasse 6
    • 82467  Garmisch-Partenkirchen
    • Germany
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Sources of Monetary or Material Support

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    • BG Unfallklinik Murnau
    • BGU Unfallklinik  Murnau 
    • Prof. Küntscherstr. 8
    • 82418  Murnau
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/03/03
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Trial Publications, Results and other Documents

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