Return to Sports After ACLR

Anterior Cruciate Ligament Injuries Clinical Trial

— RTSACL  

Official title:

Return to Sports After ACLR (RTSACL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862013
• Other study ID #: RTSACL
• Status: Completed
• 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
• 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.).

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.