Trial document





This trial has been registered retrospectively.
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  DRKS00017452

Trial Description

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Title

Reduction of postoperative blood loss by local administration of "4dryField PH" after duo-ear prosthesis implantation in patients with medial femoral neck fracture - a randomized controlled study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

A bone fracture of the femoral neck is especially affecting patients in the older age after a fall. This affects about 100,000 in Germany patients per year, with over 90% of patients older than 60 years.
It is usually the case to restore patient mobility as quickly as possible necessary to perform an operation. In the special case of a joint near
fracture, implantation of a so-called hemiprosthesis (Duo-head prosthesis) may be necessary. In this type of artificial joint replacement the socket is preserved. Only the femoral head is replaced and by means of
bone cement anchored in the femur. Shortened with this method already reduces the operation time and thus the blood loss compared to implantation of a total endoprosthesis (replacement of acetabulum and femoral head). Around to avoid further blood loss and mobility after surgery improve, we would like to continue the hemostasis in the operation area improve. This is highly purified starch in the form of a powder
("4DryField®PH", PlantTec Medical, Bad Bevensen, Germany) in the surgical wound given. The starch deprives the blood in the wound of the water and thus promotes rapid hemostasis. This study should help to shed more light on this.
Since it is at the o.g. study will be a randomized clinical srial even before the operation is determined by a random generator, whether during the Operation "4DryField®PH" applied or no application is made.
After the operation follow the clinic's internal scheme blood draws on the 1st, 3rd, and 5th postoperative day about blood loss too measure up.
In addition, an ultrasound is operated on the 7th day after surgery joint performed around a possible bruise too recognize.
In addition, we arrange an appointment about 6 weeks after the surgery for follow-up. This includes a physical examination the function of the operated hip joint in the side comparison and a renewed ultrasonic control of the operating area.

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Brief Summary in Scientific Language

In so-called bipolar hemiprostheses the femoral head is replaced and anchored in the femur by means of bone cement. The hip socket remains in contrast to the total endoprosthesis obtained. This shortens the operation time and reduces the intraoperative blood loss as well as the rate of postoperative complications.
The local application of hemostyptic substances in the operating area can significantly contribute to further reduce postoperative blood loss, thus reduce circulatory strain through reduced fluid loss, thus improving the early mobility of elderly patients.
A variety of hemostyptics was examined in knee arthroplasty replacement. The topical application of tranexamic acid and fibrin spray has been investigated. Other methods investigated for bleeding reduction, intraoperative wound irrigation with epinephrine as well as non-pharmacological techniques such as surgery involving a thigh blood lock were used. Only the intraoperative attachment of a thigh blood lock was taken into clinical routine.
For hip arthroplasty restorations tranexamic acid in the foreground. Both local and systemic use have been shown to reduce blood loss and, in part, transfusion rates. Nevertheless, this procedure has not been successful so far because there is not enough evidence.
This is the study used product "4DryField®PH" (PlantTec Medical, Bad Bevensen, Germany) is for local hemostasis and adhesion prophylaxis
authorized. This medical device carries a CE marking of Class III and was certified in Germany. 4DryField®PH is made of hydrophilic
Microparticles made from purified vegetable starch and thus is free from animal or human components. Due to the hydrophilic Properties, the water content is bound in the operation area and consecutive the clotting factors are concentrated locally, which improves blood clot formation. At the same time, a viscous gel is formed upon contact of 4DryField®PH with water, which temporarily prevents the formation of adhesions and adhesions. That's why it could also be after application hip endoprostheses cause an improvement in mobility.
The aim of this study is to study the effect of the local hemostatic drug "4DryField®PH"
the postoperative blood loss after implantation of a duo head prosthesis check patients with medial femoral neck fracture. Furthermore, the
Training hematoma / seroma sonographically examined. In addition, 6 weeks postoperatively, the function of the operated hip joint by means of functional test checked.

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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

  •   DRKS00017452
  •   2019/06/11
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  •   yes
  •   Approved
  •   08/16, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1234-6043 
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Health Condition or Problem studied

  •   S72.01 -  [generalization S72.0: Fracture of neck of femur]
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Interventions/Observational Groups

  •   - During the operation "4DryField®PH" is applied
    - The operation is performed according to the in-house-established scheme.
    There is no change regarding anesthesia, surgical access, surgical technique or type of drainage system.
    - After the procedure is performed on the 1st, 3rd and 5th postoperative day taking a laboratory control to measure the blood loss, this being to take blood samples according to the in-house scheme after surgery. There are no separate blood tests in the context of the
    study design. Furthermore, the measurement of the amount of wound secret in
    milliliters from intraoperatively introduced wound drainages. The blood values ​​determined postoperatively in laboratory controls are determined according to the
    Formula of Nadler, Hidalgo and Bloch
    PBV (men) = 0.3669 * H³ + 0.03219 * W + 0.6041
    PBV (women) = 0.3561 * H³ + 0.03308 * W + 0.1833
    (H = size in m, W = weight in kg)
    used to calculate the postoperative blood loss.
    On the 7th postoperative day, an ultrasound control of the operating area performed to exclude an operative hematoma.
    After discharge of the patient into the ambulante home care becomes one control appointment agreed 6 weeks postoperatively. At this time, a re-examination of the operated hip in the side comparison, as well as a renewed sonographic control of the operating area. In addition to the motion test after neutral zero, the HarrisHipScore (HHS) and the
    Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the subjective pain condition on the visual analog scale (VAS)
    are detected.
  •   - The procedure takes place without application of "4DryField®PH"
    - The operation is performed according to the in-house-established scheme.
    There is no change regarding anesthesia, surgical access, surgical technique or type of drainage system.
    - After the procedure is performed on the 1st, 3rd and 5th postoperative day taking a laboratory control to measure the blood loss, this being to take blood samples according to the in-house scheme after surgery. There are no separate blood tests in the context of the
    study design. Furthermore, the measurement of the amount of wound secret in milliliters from intraoperatively introduced wound drainages. The blood values ​​determined postoperatively in laboratory controls are determined according to the Formula of Nadler, Hidalgo and Bloch
    PBV (men) = 0.3669 * H³ + 0.03219 * W + 0.6041
    PBV (women) = 0.3561 * H³ + 0.03308 * W + 0.1833
    (H = size in m, W = weight in kg)
    used to calculate the postoperative blood loss.
    On the 7th postoperative day, an ultrasound control of the operating area performed to exclude an operative hematoma.
    After discharge of the patient into the ambulante home care becomes one control appointment agreed 6 weeks postoperatively. At this time, a re-examination of the operated hip in the side comparison, as well as a renewed sonographic control of the operating area. In addition to the motion test after neutral zero, the HarrisHipScore (HHS) and the
    Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the subjective pain condition on the visual analog scale (VAS)
    are detected.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

check the effect of the local hemostyptic "4DryField®PH" on the postoperative blood loss after implantation of a duo head prosthesis
with medial femoral neck fracture.

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Secondary Outcome

- Examination of the formation of a hematoma / seroma are examined sonographically
- 6 weeks postoperatively, check the function of the operated hip joint by means of functional test

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/07/24
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Patients with medial femoral neck fracture (Garden type III / IV) who are indicated for the implantation of a hemiprosthesis according to the valid standard

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Exclusion Criteria

- polytraumatized patients
- presence of an injury to the ipsilateral limb
- Patients with tumor disease
- preoperative Hb <= 6 mmol / l
- known starch allergy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik für Unfallchirurgie
    • Mr.  Prof. Dr. med.  Felix  Walcher 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Unfallchirurgie
    • Mr.  Prof. Dr. med.  Stefan  Piatek 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Unfallchirurgie/Zenrale Notaufnahme
    • Mr.  OA  Christian   Ribau 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Unfallchirurgie
    • Mr.  Prof. Dr. med.  Felix  Walcher 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/10
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Trial Publications, Results and other Documents

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