Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00020210

Trial Description

start of 1:1-Block title

Title

Regeneration of thigh muscle strength after hamstring tendon harvest for ACL-autograft - a retrospective analysis

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

Trial Acronym

VKB-RBK-2017

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

This study analyzes functional performance testing like strenght testing and hop testing and the influence of perioperative factors on the regeneration of strength after anterior cruciate ligament reconstruction.

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

Brief Summary in Scientific Language

We are performing a retrospective analysis of biomechanical performance testing following ACL-reconstruction and the evaluation of perioperative factors on the regeneration of thigh muscle strength.

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?

No

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

  •   DRKS00020210
  •   2020/02/12
  •   [---]*
  •   yes
  •   Approved
  •   EKNZ-2017-01825, Ethikkommission Nordwestschweiz
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

  •   S83.53 -  [generalization S83.5: Sprain and strain involving (anterior)(posterior) cruciate ligament of knee]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Retrospective analysis of patients undergoing acl (anterior cruciate ligament) reconstruction and functional performance testing from 2015-2018.
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

Limb symmetry in thigh muscle strength 6 months after ACL (anterior cruciate ligament) reconstruction.

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

Secondary Outcome

Perioperative factors influencing postoperative performance and thigh muscle strength.

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

Countries of Recruitment

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

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/06/03
  •   800
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

ACL reconstruction at Rennbahnklinik Muttenz

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

Exclusion Criteria

Denial of consent

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Praxisklinik Rennbahn AG
    • Mr. 
    • Kriegackerstr. 100
    • CH-4132  Muttenz
    • Switzerland
    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
    • Praxisklinik Rennbahn AG
    • Ms.  PD Dr.   Ramona  Ritzmann 
    • Kriegackerstr. 100
    • CH-4132  Muttenz
    • Switzerland
    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
    • Universitätsklinikum FreiburgKlinik für Orthopädie und Unfallchirurgie
    • Mr.  Dr.  Markus  Wenning 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • 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
    • Praxisklinik Rennbahn AG
    • Kriegackerstr. 100
    • CH-4132  Muttenz
    • Switzerland
    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 complete, follow-up continuing
  •   [---]*
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.