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

Conditions

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

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital

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
Procedure: Patients with Cyclop lesion
Arthroscopy with resection of Cyclop formation
Patients without Cyclop lesion
Patients without no arthroscopy within 2 years after primary surgery
Procedure: Patients with Cyclop lesion
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

Aarhus University Hospital

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.

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