Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010055

Trial Description

start of 1:1-Block title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http:///

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

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
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   S43.1 -  Dislocation of acromioclavicular joint
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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 .

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/02/22
  •   40
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

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
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Orthopädische Praxis/ Praxisklinik (OPPK) Münster
    • Mr.  Prof. Dr. med.  Jörn  Steinbeck 
    • Von-Vincke-Str. 14
    • 48143  Münster
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Orthopädische Praxis/ Praxisklinik (OPPK) Münster
    • Mr.  Prof. Dr. med.  Jörn  Steinbeck 
    • Von-Vincke-Str. 14
    • 48143  Münster
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Orthopädische Praxis/ Praxisklinik (OPPK) Münster
    • Mr.  Prof. Dr. med.  Jörn  Steinbeck 
    • Von-Vincke-Str. 14
    • 48143  Münster
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.