Trial document




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  DRKS00014714

Trial Description

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Title

Induced Anterior Cruciate Ligament healing with the Ligamys technique:
a prospective, two-center interventional 1-arm study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Documentation of the Ligamys implant in promoting the natural healing of a torn ACL. A total of at least 150 patients whose Ligament Tear has been treated with Ligamys are included in the study and followed up for 2 years.

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Brief Summary in Scientific Language

Study design
Prospective interventional open-label single-arm non-comparative study evaluating the effectiveness and safety of the Ligamys System. The study is carried out in two-centers. The total follow-up duration is 24 months. An interim analysis is planned once 50% of the patients are available for evaluation at 12 months follow-up. Number of study patients N = 150.
Follow-up
•6 weeks
•3 months (optional)
•6 months
•12 months
•24 months

Primary endpoint
Knee stability (translation): an increased translation of the knee joint is the typical consequence of the ruptured ACL. This leads to an unpleasant feeling of instability (giving way phenomenon), especially for the more active patients, to a decreased knee and overall physical function, and eventually to knee pain and secondary osteoarthritis. The instability is measured in a standardized fashion with the Lachman test by means of a Rolimeter or KT 1000/2000. Pre- to postoperative translation difference will be assessed as well as the postoperative difference compared with the healthy contralateral side. A difference >3mm is considered as non-desired outcome. The knee stability will be assessed at each follow-up until 2 years after surgery and statistically evaluated at the 12 months follow-up.

The primary results include the improvement of the knee joint stability (Lachman test), the knee joint function (Lysholm score, IKDC 2000 score, activity score according to Tegner Lysholm). Reaching the ligamentary normal function of the knee joint.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014714
  •   2018/05/07
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  •   no
  •   Approved
  •   Eth-05/18, Ethik-Kommission der Ärztekammer Berlin
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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

  •   Augmentation of the anterior cruciate ligament, dynamic intraligamentary stabilization.
    Clinical follow-up will be performed after 6 weeks, 3 (optional), 6, 12, 24 months.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary patient outcomes will include improvement in knee joint stability (Lachman test), knee joint function (Lysholm Score, IKDC Score); safety.
Follow-up
•6 weeks
•3 months (optional)
•6 months
•12 months
•24 months

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Secondary Outcome

•Patient satisfaction
•Work Absence
After 3 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2018/11/16
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Primary tear of the anterior cruciate ligament
• Signed by the patient Consent form.
• readiness of the patient's follow-up appointments Observed.
• Age between 18 and 65 years at the time of Study inclusion.
• Time interval between trauma and surgery 21 days
• Meniscal suture

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Exclusion Criteria

1.Medical non-compliance
2.Unwillingness to follow the rehabilitation programme
3.Traumatic cartilage lesion requiring cartilage repair procedures (Microfracturing, MACI, ACT) or degenerative cartilage lesions (Outerbridge >II and defect >1cm2)
4.Non-repairable meniscus lesions requiring a resection of >20%
5.Previous tendon removal on injured leg
6.Relevant permanent medication (steroids, cytostatic drugs, …)
7.Pregnancy (Before the beginning of the trial, women capable of childbearing will be tested for pregnancy)

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Addresses

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    • Mathys Orthopädie GmbH
    • Seilfahrt 99
    • 44809  Bochum
    • Germany
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    • Mathys Orthopädie GmbH
    • Ms.  Natividad  Zeleny 
    • Seilfahrt 99
    • 44809  Bochum
    • Germany
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    • Mathys Orthopädie GmbH
    • Ms.  Natividad  Zeleny 
    • Seilfahrt 99
    • 44809  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Mathys AG Bettlach
    • Robert Mathys Strasse 5
    • 2544  Bettlach
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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