Trial document




This trial has been registered retrospectively.
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  DRKS00010055

Trial Description

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Title

Clinical results of arthroscopic treatment of acute acromioclavicular joint dislocations by use of TightRope® and Dog Bone® and chronic acromioclavicular joint instabilities by use of TightRope® and autologous Gracilis-Graft

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Trial Acronym

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URL of the Trial

http:///

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Brief Summary in Lay Language

Dislocations of the acromioclavicular joint are one of the most common injuries of the shoulder girdle especially in athletic people. In Germany the frequency of new injuries is 18 cases/100.000 people. Without medical treatment the injury leads to chronic instability of the shoulder girdle with restrictions of shoulder motion, pain and early aromioclavicular joint osteoarthritis. Actually there is no golden standard in the treatment of acromioclavicular joint dislocations. Formerly open reconstructions were carried out commonly. Since several years arthroscopic techniques became more and more popular. Studies about artrhoscopic techniques show less complications, less side effects and an improved aftercare. The aim of our study is to assess if the employment of the TightRope and Dog Bone System (Arthrex, Naples, Florida) provides satisfactory clinical results in combination with a low complication rate in cases of acute and chronic aromioclavicular joint instability. The described procedures are supposed to improve the patients shoulder function in combination with pain reduction and an improvement of life quality.

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Brief Summary in Scientific Language

On the one hand this study collects and evaluates data from patients with acute acromioclavicular joint dislocation of Rockwood types III-VI, which were treated arthroscopically by the TightRope®- and DogBone technique. On the other hand the study collects and evaluates the data from patients with chronic acromioclavicular joint instabilities of Rockwood types III-VI, which were treated arthroscopically by a Dog Bone® and an autologous gracilis-graft. The coracoclavicular distance (CCD) is determined and evaluated radiologically directly after surgery and one year postoperatively in stress radiographs. Further more clinical scores ( Constant Shoulder Score / ASES - score ) are collected preoperatively and after one year. The hypothesis is, that the CCD does not change after one year and that the clinical results improve. Additionally this study investigates, if patients with acute acromioclavicular joint dislocations and chronic acromioclavicular joint instabilities benefit equally from the operation. Further this study assesses if the arthroscopic techniques lead to a complete redression of the horizontal instability (type IV Rockwood) of acute and chronic acromioclavicular joint injuries.

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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

  •   DRKS00010055
  •   2016/03/22
  •   [---]*
  •   yes
  •   Approved
  •   2015-579-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   S43.1 -  Dislocation of acromioclavicular joint
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Interventions/Observational Groups

  •   On the one hand this study collects and evaluates data from patients with acute acromioclavicular joint dislocation of Rockwood types III-VI, which were treated arthroscopically by the TightRope®- and DogBone technique. On the other hand the study collects and evaluates the data from patients with chronic acromioclavicular joint instabilities of Rockwood types III-VI, which were treated arthroscopically by a Dog Bone® and an autologous gracilis-graft. The coracoclavicular distance (CCD) is determined and evaluated radiologically directly after surgery and one year postoperatively in stress radiographs. Further more clinical scores ( Constant Shoulder Score / ASES - score ) are collected preoperatively and after one year.
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Characteristics

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

Reduction of radiological coracoclavicular distance ( CCD ) preoperative compared to directly postoperative, and retention of these results directly postoperative compared to 12 months postoperative .

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Secondary Outcome

Reduction of radiological horizontal instability of the lateral clavicle preoperative compared to directly and retention of these results directly postoperative compared to 12 months postoperative/ patient satisfaction by use of visual analogue scale after 12 months postoperative / improvement of clinical scores preoperative compared to 12 months postoperative

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/02/22
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

acute acromioclavicular joint dislocation of Rockwood grade III and higher
chronic acromioclavicular joint instability of Rockwood grade III and higher

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Exclusion Criteria

- minors
- adults, who are unable to consent
- associated clavicula fractures
- nerve and vessel lesions
- further associated fractures of the shoulder girdle
- infections
- open acromioclavicular joint dislocations
- dislocation of the glenohumeral joint
- alkohol abuse
- ASA stadium IV and V
- previous shoulder replacement
- Osteoarthritis of the glenohumeral joint

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Orthopädische Praxis/ Praxisklinik (OPPK) Münster
    • Mr.  Prof. Dr. med.  Jörn  Steinbeck 
    • Von-Vincke-Str. 14
    • 48143  Münster
    • Germany
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    • Orthopädische Praxis/ Praxisklinik (OPPK) Münster
    • Mr.  Prof. Dr. med.  Jörn  Steinbeck 
    • Von-Vincke-Str. 14
    • 48143  Münster
    • Germany
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    • Orthopädische Praxis/ Praxisklinik (OPPK) Münster
    • Mr.  Prof. Dr. med.  Jörn  Steinbeck 
    • Von-Vincke-Str. 14
    • 48143  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Orthopädische Praxis/ Praxisklinik (OPPK) Münster
    • Mr.  Prof. Dr. med.  Jörn  Steinbeck 
    • Von-Vincke-Str. 14
    • 48143  Münster
    • Germany
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Status

  •   Recruiting ongoing
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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.