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?

Sponsor

Aarhus University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05301686

Collaborator

(none)

3,000

Enrollment

Location

Anticipated Duration (Months)

199.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cyclop Arthrofibrosis Anterior Cruciate Ligament	Procedure: Patients with Cyclop lesion

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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.

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Cyclop lesion [2 years]
Incidence of Arthroscopy with removal of Cyclop formation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Patient >18 years
Primary ACL reconstruction

Exclusion Criteria:

Multiligament reconstruction
Revisions
ACL reconstruction with double bundle graft

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus N		Denmark	8200

Sponsors and Collaborators

Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Martin Lind, Professor, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT05301686

Other Study ID Numbers:

EC: 1-10-72-274-21

First Posted:

Mar 31, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 31, 2022