Is There a Correlation Between Surgical Technique for Pri... | NCT05301686

Studies
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?

NCT05301686

Sponsor

Aarhus University Hospital

Status

Completed

Last Update Posted

Jan 18, 2023Actual

Enrollment

2,556Actual

Phase

Not provided

Conditions

Cyclop Arthrofibrosis Anterior Cruciate Ligament

Interventions

Patients with Cyclop lesion

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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.

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Jul 1, 2022Actual

Completion Date

Jan 1, 2023Actual

First Submitted Date

Mar 20, 2022

First Submission Date that Met QC Criteria

Mar 20, 2022

First Posted Date

Mar 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2023

Last Update Posted Date

Jan 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,556Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
Patients without Cyclop lesion		Patients without no arthroscopy within 2 years after primary surgery	Procedure: Patients with Cyclop lesion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients with Cyclop lesion	Procedure	Arthroscopy with resection of Cyclop formation	Patients with Cyclop lesion Patients without Cyclop lesion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cyclop lesion	Incidence of Arthroscopy with removal of Cyclop formation	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient >18 years
Primary ACL reconstruction

Exclusion Criteria:

Multiligament reconstruction
Revisions
ACL reconstruction with double bundle graft

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary ACL reconstructed patients operated in the period 2005-2019

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus N		8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.