Trial document




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  DRKS00015654

Trial Description

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Title

Prospective-randomized trial on the postoperative outcome after MPFL reconstruction with autologous tendon graft vs. artificial grafts (FiberTape)

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Trial Acronym

MPFLGTVSFT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is a clinical trial on the postoperative outcome after medial patellofemoral ligament (MPFL) reconstruction, which is torn in most cases of patellar dislocation. The MPFL acts as a main stabilizer of the patellar against lateral dislocation.
For graft choice, mostly tendon material which can be harvested from the patient's thigh can be used. These are the same tendons, which can be used for reconstructions of the anterior cruciate ligament (ACL).
However, when using autologous tendons, a complication rate of up to 25% can be observed, including postoperative Hematoma, local pain syndrome or loss of strength. This is why artificial graft material has been taken into consideration, however, only one study has aimed to compare the clinical outcomes of both techniques.
This study includes all patients who suffer from recurring patellar dislocations, due to a torn MPFL and/or a lateralized tibial tubercle. Other than that, no further pathologies of the knee should be present.
In order to gather genuine results, the choice of the graft will be made randomly.
The clinical examination will be conducted preoperatively, as well as 6, 12, 14 and 28 months postoperatively, completed by standardized surveys. On grounds of current literature we have reason to believe, that clinical outcomes after stabilization with artificial grafts is equally successful as with autologous tendon grafts. Furthermore we believe, that by using artificial grafts, postoperative pain and loss of strength may be very well reduced.
Additionally the patients' tendons will be spared and further available in case they are required for further surgeries, such as ACL reconstruction.

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Brief Summary in Scientific Language

The medial patellofemoral ligament (MPFL) acts as the main stabilizer against mediolateral translation in 0-30° of flexion and antagonizes up to 60% of laterally vectored patellar motion. In over 90% of all cases of patellar instability the MPFL is torn, increasing lateral translation by 50%.
Therefore MPFL-reconstruction is one of the most important surgical procedures to restabilize the patellar. If accompanying pathologies, such as genu valgum, increase of tibial tuberosity to trochlear groove (TT-TG) distance, patella alta, torsional deformities or trochlea dysplasia are radiologically excluded, MPFL reconstruction is a safe and reliable procedure for patellar stabilization.
As a graft choice, autologous tendon grafts, such as the hamstring tendons (gracilis or semitendinosus tendon) have become a popular transplant. Further, the quadriceps tendon has been described to be a suitable transplant, as it is in anterior cruciate ligament (ACL) reconstruction. However, autologous tendon grafts are limited in quality and quantity. Also, the incidence of donor site morbidity, such as pain, swelling, hematoma or loss of strength, has been described in up to 25% of all cases.
Against this background artificial graft material has been taken into consideration, to reduce donor site morbidity and to spare autologous tendons.
A recent prospective study has found good clinical results after MPFL reconstruction, using artificial grafts, comparing autologous to artificial grafts.
However, choice of grafts is often guided by personal or patient individual factors, which poses the risk of generating a bias in data analysis. Moreover, further accompanying pathologies which might increase the risk of patellar instability, must be excluded explicitly, to ensure a homogenous collective.
We will include adult patients, suffering from recurrent patellar dislocations, who present a torn MPFL and/or increased TT-TG, without showing further pathologies. Clinical examination will be conducted preoperatively, as well as 6, 12, 24 and 48 months postoperatively. On these grounds, a prospective randomized trial, comparing the clinical outcome after MPFL reconstruction with autologous of artificial grafts would be possible.
To our best knowledge, here are no comparable studies.
We primarily hypothesize that MPFL reconstruction with artificial grafts (FiberTape) will lead to a non-inferior clinical outcome, considering redislocation rate and functional outcome (Lysholm Score). Secondarily, we hypothesize that patient activity (Tegner activity index) and pain (VAS, Kujala Score) will improve equally, however possibly leading to a reduced donor site morbidity and loss of strength.

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Organizational Data

  •   DRKS00015654
  •   2018/10/10
  •   [---]*
  •   no
  •   Approved
  •   PV5788, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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

  •   M22.0 -  Recurrent dislocation of patella
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Interventions/Observational Groups

  •   MPFL reconstruction with tendon graft:

    Harvesting of the tendon at pes anserinus
    - skin incision
    - preparation of tendon
    - stripping from muscle
    - arming the tendon with vicryl sutures.

    MPFL reconstruction
    - medial parapatellar skin incision
    - preparation of medial patellar edge
    - preparation of groove in medial edge
    - implantation of two suture anchors
    - stab incision over distal medial femur
    - implantation of eyelit wire at Schöttle point (X-ray)
    - over reaming with 6mm diameter
    - fixation of graft in prepared patellar groove
    - preparation between 2nd/3rd plane to femur
    - shuttling of graft to the femur
    - shuttling of graft through drill channel
    - verification of isometry
    - stressles fixation of graft with interference screw
    - subcutaneous and skin sutures
    - standardized MPFL rehabilitation protocol
  •   MPFL reconstruction with FiberTape

    - medial parapatellar skin incision
    - preparation of medial patellar edge
    - preparation of groove in medial edge
    - implantation of two suture anchors
    - stab incision over distal medial femur
    - implantation of eyelit wire at Schöttle point (X-ray)
    - over reaming with 6mm diameter
    - fixation of graft in prepared patellar groove
    - preparation between 2nd/3rd plane to femur
    - shuttling of graft to the femur
    - shuttling of graft through drill channel
    - verification of isometry
    - stressles fixation of graft with interference screw
    - subcutaneous and skin sutures
    - standardized MPFL rehabilitation protocol
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

redislocation rate after 12, 24 and 48months

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Secondary Outcome

Kujala-Score, Tegner Activity Index, donor site morbidity and strength after 12, 24 and 48 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2018/11/01
  •   90
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

recurring patellar dislocations (>2)
MPFL tear
closed epiphyseal plates
partly increased TT-TG

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Exclusion Criteria

open epiphyseal plates
further predisposing anatomical factors
single or traumatic dislocation
complex trauma of knee
accompanying injuries of the knee

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Addresses

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    • Arthrex GmbH
    • Erwin-Hielscher-Strasse 9
    • 81249  München
    • Germany
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    • Abteilung für Unfall-, Hand- und WiederherstellungschirurgieUniversitätsmedizin Hamburg-Eppendorf
    • Mr.  Professor Dr. med.  Karl-Heinz  Frosch 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Abteilung für Unfall-, Hand- und WiederherstellungschirurgieUniversitätsmedizin Hamburg-Eppendorf
    • Mr.  Dr. med.  Jannik  Frings 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Arthrex GmbH
    • Erwin-Hielscher-Strasse 9
    • 81249  München
    • Germany
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Status

  •   Recruiting planned
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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.