Trial document




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  DRKS00008564

Trial Description

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Title

Supplementary arthrolysis of the proximal interphalangeal joint of fingers in operative treatment of Dupuytren's contracture

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Trial Acronym

arthrolysis of the proximal interphalangeal joint

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Clinical follow-up of 33 patients with Dupuytren's flexion contracture of fingers who were treated operatively between January 2012 and December 2014 by supplementary arthrolysis of the proximal interpahalangeal (PIP) joint beside fasciectomy.The current joint position of the PIP joint will be measured with a goniometer, satisfaction with the result will be documented on a visual analogue scale (0-10 points) and the DASH (Disabilities of the Arm, Shoulder and Hand) score will be calculated. The data will be compared to preoperative data retrospectively.

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Brief Summary in Scientific Language

In the surgical treatment of Dupuytren's flexion contracture of the finger in some cases a flexion contracture of the proximal interphalangeal (PIP) joint remains after removal of the diseased connective tissue. This is a consequence of chronic flexion and is caused by shortening, shrinkage and bonding of the surrounding joint structures. So far, there are few studies that deal with the results for a supplementary arthrolysis of the PIP joint [1-7].
33 patients with Dupuytren's flexion contracture, in which a supplenetory artholysis of the PIP joint was performed beside partial fasciectomy will be followed up clinically for an average of 22 months.
References
1. Belusa L, Buck-Gramcko D, Partecke BD (1997) Ergebnisse von Mittelgelenkarthrolysen bei Patienten mit Dupuytren-Erkrankungen. Handchir Mikrochir Plast Chir 29:158-163
2. Beyermann K, Jacobs C, Lanz U (1999) Severe Contractures of the Proximal Interphalangeal Joint in Dupuytren's Disease:Value of Capsuloligamentous Release. Hand Surg 4:57-61
3. Beyermann K, Jacobs C, Prommersberger KJ et al (2002) Die fortgeschrittene Dupuytrensche Kontraktur des Mittelgelenkes: Ist die Arthrolyse bei fortbestehender Fehlstellung nach Resektion des Kontrakturgewebes sinnvoll? Handchir Mikrochir Plast Chir 34:123-127
4. Beyermann K, Prommersberger KJ, Jacobs C et al (2004) Severe contracture of the proximal interphalangeal joint in Dupuytren's disease: does capsuloligamentous release improve outcome? J Hand Surg Br 29:240-243
5. Haßelbacher K, Bleuel S, Landsleitner B (2002) Langzeitergebnisse nach beugeseitiger Mittelgelenkarthrolyse. Handchir Mikrochir Plast Chir 34:355-362
6. Watson HK, Light TR, Johnson TR (1979) Checkrein resection for flexion contracture of the middle joint. J Hand Surg Am 4:67-71
7. Weinzweig N, Culver JE, Fleegler EJ (1996) Severe contractures of the proximal interphalangeal joint in Dupuytren's disease: combined fasciectomy with capsuloligamentous release versus fasciectomy alone. Plast Reconstr Surg 97:560-566

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Organizational Data

  •   DRKS00008564
  •   2015/05/20
  •   [---]*
  •   yes
  •   Approved
  •   15-124, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   M72.0 -  Palmar fascial fibromatosis [Dupuytren]
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Interventions/Observational Groups

  •   Observasional study:
    Clinical follow-up of 33 patients with Dupuytren's flexion contracture of fingers who were treated operatively between January 2012 and December 2014 by supplementary arthrolysis of the proximal interpahalangeal (PIP) joint beside fasciectomy after an average of 22 months.The current joint position of the PIP joint will be measured with a goniometer, satisfaction with the result will be documented on a visual analogue scale (0-10 points) and the DASH (Disabilities of the Arm, Shoulder and Hand) score will be calculated. The data will be compared to preoperative data retrospectively.
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Characteristics

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

Measurement of the current joint position of the PIP joint with a goniometer.

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Secondary Outcome

Documentation of satisfaction with the result of the operation by a visual analogue scale (0-10 points); calculation of the DASH (Disabilities of the Arm, Shoulder and Hand) score; comparision of the data to preoperative data.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/06/02
  •   33
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

33 patients with Dupuytren's flexion contracture of fingers who were treated operatively between January 2012 and December 2014 by supplementary arthrolysis of the proximal interpahalangeal (PIP) joint beside fasciectomy.

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Exclusion Criteria

none

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Elbe Klinikum Stade
    • Mr.  Priv.-Doz. Dr. med.  Bernd  Hohendorff 
    • Bremervörder Straße 111
    • 21682  Stade
    • Germany
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    • Elbe Klinikum Stade
    • Mr.  Priv.-Doz. Dr. med.  Bernd  Hohendorff 
    • Bremervörder Straße 111
    • 21682  Stade
    • Germany
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    • Elbe Klinikum Stade
    • Mr.  Priv.-Doz. Dr. med.  Bernd  Hohendorff 
    • Bremervörder Straße 111
    • 21682  Stade
    • Germany
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Sources of Monetary or Material Support

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    • Elbe Klinikum Stade
    • Mr.  Priv.-Doz. Dr. med.  Bernd  Hohendorff 
    • Bremervörder Straße 111
    • 21682  Stade
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/06/30
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* This entry means the parameter is not applicable or has not been set.