Anterior Cruciate Ligament InjuriesRTSACLNCT04862013
Return to Sports After ACLR
An observational study of Anterior Cruciate Ligament Injuries and Reconstruction, run by crossklinik AG at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Reconstruction
- How many people
- 133 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18
- ACL injury
- surgically treated with ACL reconstruction at the crossklinik or affiliated institutions between 1.1.2013 and 31.12.2018
Who cannot join
- different treatment approach to the injury (e.g. conservative, stimulation of healing response, surgical treatment for re-rupture etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- anterior cruciate ligament injuries, return to sport
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until return to sport
This will be based on a self reporting by the patient.
Measured: 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
Measured: 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
Muscle strength is assessed by considering the flexion/extension ratio. This data will be collected retrospectively form the medical records,
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- crossklinik AG
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Basel Academy for Quality and Research in Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862013
- Sponsor's protocol ID
- RTSACL
- Acronym
- RTSACL
- Status last verified
- Jul 2022
- First submitted
- 2 Mar 2021
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be made available on request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Sports After ACLR (RTSACL)
- ClinicalTrials.gov ID
- NCT04862013
- Acronym / sponsor ID
- RTSACL / RTSACL
- Keywords
- anterior cruciate ligament injuries, return to sport
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- crossklinik AGUniversity, hospital or other
- Collaborators
- University of Basel, Basel Academy for Quality and Research in Medicine
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥18
- ACL injury
- surgically treated with ACL reconstruction at the crossklinik or affiliated institutions between 1.1.2013 and 31.12.2018
Key exclusion criteria (1 listed)
- different treatment approach to the injury (e.g. conservative, stimulation of healing response, surgical treatment for re-rupture etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
2 secondary outcomes
Average Muscle Strength
Time frame: At 1 year follow up.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Undecided. The data will be made available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries and Reconstruction, run by crossklinik AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.