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Return to Sports After ACLR (RTSACL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04862013
Recruitment Status : Enrolling by invitation
First Posted : April 27, 2021
Last Update Posted : July 28, 2021
Sponsor:
Collaborators:
University of Basel
Basel Academy for Quality and Research in Medicine
Information provided by (Responsible Party):
crossklinik AG

Study Description
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Brief 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.

Condition or disease
Anterior Cruciate Ligament Injuries Reconstruction

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Return to Sports After ACLR (RTSACL)
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 30, 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Time until return to sport [ Time Frame: 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. ]
    This will be based on a self reporting by the patient.

  2. Occurrence of a subsequent injury after return to sport [ Time Frame: 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. ]
    This will be based on the self reporting by the patient


Secondary Outcome Measures :
  1. Average Muscle Strength [ Time Frame: At 1 year follow up. ]
    Muscle strength is assessed by considering the flexion/extension ratio. This data will be collected retrospectively form the medical records,

  2. Relative frequency of coping strategies [ Time Frame: 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. ]
    A series of questions about the impact of the injury on the life of the patients will be answered by the patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients of age ≥18, who had an ACL injury and were surgically treated with ACL reconstruction at the crossklinik or affiliated institutions between 1.1.2013 and 31.12.2018 by a small group of experienced surgeons will be included in the study.
Criteria

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.).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862013


Locations
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Switzerland
crossklinik AG
Basel, Switzerland, 4054
Sponsors and Collaborators
crossklinik AG
University of Basel
Basel Academy for Quality and Research in Medicine
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: crossklinik AG
ClinicalTrials.gov Identifier: NCT04862013    
Other Study ID Numbers: RTSACL
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data will be made available on request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by crossklinik AG:
anterior cruciate ligament injuries
return to sport
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries