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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04862013
Other study ID # RTSACL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2021

Study information

Verified date July 2022
Source crossklinik AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients who were surgically treated with ACL reconstruction at a single clinic between 2013 and 2018 will be approached by a questionnaire regarding their return to sport after surgery. Questions will focus on the timepoint of the return, subsequent injuries, and the impact of the initial injury on the life of the patients. In addition, existing clinical data from the baseline visit and from the follow-up visits offered routinely to the patient will be used.


Recruitment information / eligibility

Status Completed
Enrollment 133
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 - ACL injury - surgically treated with ACL reconstruction at the crossklinik or affiliated institutions between 1.1.2013 and 31.12.2018 Exclusion Criteria: - different treatment approach to the injury (e.g. conservative, stimulation of healing response, surgical treatment for re-rupture etc.).

Study Design


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injuries

Locations

Country Name City State
Switzerland crossklinik AG Basel

Sponsors (3)

Lead Sponsor Collaborator
crossklinik AG Basel Academy for Quality and Research in Medicine, University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time until return to sport This will be based on a self reporting by the patient. All patients will be asked in a cross sectional assessment, i.e. at one specific date (planned: May 31, 2021). The distance of this time point to the time of surgery will vary between 2 and 8 years.
Primary Occurrence of a subsequent injury after return to sport This will be based on the self reporting by the patient All patients will be asked in a cross sectional assessment, i.e. at one specific date (planned: May 31, 2021). The distance of this time point to the time of surgery will vary between 2 and 8 years.
Secondary Average Muscle Strength Muscle strength is assessed by considering the flexion/extension ratio. This data will be collected retrospectively form the medical records, At 1 year follow up.
Secondary Relative frequency of coping strategies A series of questions about the impact of the injury on the life of the patients will be answered by the patients All patients will be asked in a cross sectional assessment, i.e. at one specific date (planned: May 31, 2021). The distance of this time point to the time of surgery will vary between 2 and 8 years.
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