NCT04862013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 9, 2024

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

March 2, 2021

Last Update Submit

April 8, 2024

Conditions

Keywords

anterior cruciate ligament injuriesreturn to sport

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Average Muscle Strength

    At 1 year follow up.

  • Relative frequency of coping strategies

    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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age ≥18
  • ACL injury
  • surgically treated with ACL reconstruction at the crossklinik or affiliated institutions between 1.1.2013 and 31.12.2018

You may not qualify if:

  • different treatment approach to the injury (e.g. conservative, stimulation of healing response, surgical treatment for re-rupture etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

crossklinik AG

Basel, 4054, Switzerland

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

April 27, 2021

Study Start

June 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 9, 2024

Record last verified: 2022-07

Locations