Is There a Correlation Between Surgical Technique for Primary Anterior Cruciate Ligament Surgery and the Risk of Subsequent Formation of Fibrous Cyst (Cyclops) in the Knee Joint, Which Leads to the Need for Surgical Removal of the Cyclops?
January 17, 2023 updated by: Martin Lind, Aarhus University Hospital
Is There a Correlation Between Surgical Technique for Primary Anterior Cruciate Ligament Surgery and the Risk of Subsequent Formation of Fibrous Cyst (Cyclops) in the Knee Joint, Which Leads to the Need for Surgical Removal of the Cyclops? A Registry Study With Patients Operated on With Cruciate Ligament Reconstruction at Aarhus University Hospital From 2005-2019.
Fibrous scar tissue formation (Cyclops) after a primary anterior cruciate ligament reconstruction (ACLr) may affect patients' ability to perform work and exercise to such an extent that further arthroscopic surgery may be necessary.
The purpose of the study is to estimate the 2-year incidence of removal of cyclops lesion after ACLr for a cohort of approximal 3000 patients operated at Aarhus University Hospital in the period 2005-2019.
Specifically, change in surgical technique and graft choice will be analyzed.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2556
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Aarhus N, Denmark, 8200
- Aarhus University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary ACL reconstructed patients operated in the period 2005-2019
Description
Inclusion Criteria:
- Patient >18 years
- Primary ACL reconstruction
Exclusion Criteria:
- Multiligament reconstruction
- Revisions
- ACL reconstruction with double bundle graft
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with Cyclop lesion
Patients with an anterior cruciate ligament reconstruction with a symptomatic Cyclop lesion leading to a arthroscopy within 2 years after primary surgery
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Arthroscopy with resection of Cyclop formation
|
|
Patients without Cyclop lesion
Patients without no arthroscopy within 2 years after primary surgery
|
Arthroscopy with resection of Cyclop formation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cyclop lesion
Time Frame: 2 years
|
Incidence of Arthroscopy with removal of Cyclop formation
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Actual)
July 1, 2022
Study Completion (Actual)
January 1, 2023
Study Registration Dates
First Submitted
March 20, 2022
First Submitted That Met QC Criteria
March 20, 2022
First Posted (Actual)
March 31, 2022
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 17, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- EC: 1-10-72-274-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.