Cyclop Arthrofibrosis Anterior Cruciate LigamentNCT05301686
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?
An observational study of Cyclop Arthrofibrosis Anterior Cruciate Ligament, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cyclop Arthrofibrosis Anterior Cruciate Ligament
- What is being tested?
- Patients with Cyclop lesion
- Type of treatment
- Surgery or procedure
- How many people
- 2,556 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2021to 1 Jan 2023
- How long will I take part?
- 2 Years
- 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
- Adult, Older adult
Study population: Primary ACL reconstructed patients operated in the period 2005-2019
Who may be able to join
- Patient >18 years
- Primary ACL reconstruction
Who cannot join
- Multiligament reconstruction
- Revisions
- ACL reconstruction with double bundle graft
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Patients with Cyclop lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with Cyclop lesionProcedure or surgery
Arthroscopy with resection of Cyclop formation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Patients with Cyclop lesion | |
| Patients without Cyclop lesion | Patients without no arthroscopy within 2 years after primary surgery Receives: Procedure: Patients with Cyclop lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyclop lesion
Incidence of Arthroscopy with removal of Cyclop formation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Oct 2021
- Primary completion1 Jul 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclop Arthrofibrosis Anterior Cruciate LigamentStudies 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
- Other
- Enrolment
- 2,556 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lind, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301686
- Sponsor's protocol ID
- EC: 1-10-72-274-21
- Status last verified
- Jan 2023
- First submitted
- 20 Mar 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05301686
- Acronym / sponsor ID
- EC: 1-10-72-274-21
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,556 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 31 Mar 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Cyclop lesion | – | Procedure: Patients with Cyclop lesionPatients with an anterior cruciate ligament reconstruction with a symptomatic Cyclop lesion leading to a arthroscopy within 2 years after primary surgery |
| Patients without Cyclop lesion | – | Procedure: Patients with Cyclop lesionPatients without no arthroscopy within 2 years after primary surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Primary ACL reconstructed patients operated in the period 2005-2019
Key inclusion criteria (2 listed)
- Patient >18 years
- Primary ACL reconstruction
Key exclusion criteria (3 listed)
- Multiligament reconstruction
- Revisions
- ACL reconstruction with double bundle graft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with Cyclop lesionArthroscopy with resection of Cyclop formation | Procedure or surgery | Patients with Cyclop lesion, Patients without Cyclop lesion |
Primary outcome
Cyclop lesion
Time frame: 2 years
Incidence of Arthroscopy with removal of Cyclop formation
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 18 Jan 2023.
- Individual participant dataSharing planned: No
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 Cyclop Arthrofibrosis Anterior Cruciate Ligament, run by Aarhus University Hospital at 1 site in Denmark.
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 2 inclusion and 3 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 18 Jan 2023. 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 Denmark. 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?
Cyclop lesion (time frame: 2 years). 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 18 Jan 2023.