Return to Sports After ACLR (RTSACL)

Return to Sports After ACLR (RTSACL)

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Injuries; Reconstruction

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4054
    • crossklinik AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: crossklinik AG
• Collaborators: University of Basel; Basel Academy for Quality and Research in Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: return to sport; anterior cruciate ligament injuries
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: RTSACL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be made available on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No