ArthroscopyNCT04370678
Changes in Preference for Surgery of Patients Signed up for Arthroscopic Procedures
An observational study of Arthroscopy, run by Region Zealand at 1 site in Denmark.
Trial summary
This study describes the changes in preference to arthroscopic surgery in two orthopedics departments in Denmark under the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopy
- What is being tested?
- Change in preference to surgery under COVID-19 pandemic.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 79 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Apr 2020to 24 Apr 2020
- 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: All patients planned for arthroscopic procedures at Zealand University Hospital in Køge in the time period 13-4-20 to 10-5-20.
Who may be able to join
- Patients planned for arthroscopic intervention in knee or shoulder.
- Patients seen by an orthopedic surgeon and planned for surgery before 13/3-20
Who cannot join
- Surgery performed in another hospital
- Death
- Emigration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Preference for Surgery of Patients Signed up for Arthroscopic Procedures: COVID-19 Effect on Arthroscopic Patients in a University Hospital in Denmark
This study describes the changes in preference to arthroscopic surgery in two orthopedics departments in Denmark under the COVID-19 pandemic.
Read the detailed description
Background:
Covid-19 has impacted all aspects of society. In hospitals around the world focus has been on treating the deadly virus, and elective orthopedic surgical procedures has been postponed in Denmark, causing a stop for most arthroscopic procedures for months. It is established that certain conditions leading to arthroscopic orthopedic intervention has fluctuating symptoms symptoms and can have a favorable outcome on conservative treatment. Amongst these conditions who are also treated with non-surgical methods are subacromial decompression impingement[1][1], degenerative knee disease [2] and anterior cruciate ligament injuries[3]. An issue with further understanding the non-surgical effect on this patient group has beencould be reluctance to undergo conservative non-surgical treatment and opt for a surgical treatment. procedure. Because all elective surgery has been postponed in Denmark, and the following longer waiting period for surgery, this has created a unique opportunity to further investigate this patient category.
Aim of study: Investigate the impact of time on waiting list for surgery under COVID-19 pandemic on the preference for surgery in patients planned for arthroscopic surgery.
Discussion The current study will provide information on the change of preferences forto arthroscopic surgery in a patient population who are forced to wait for surgery for a longer period of time, with no possibility of seeking treatment in other hospitals.
- Conditions
- Arthroscopy
- Being tested
- Change in preference to surgery under COVID-19 pandemic.
- Keywords
- arthroscopy, shoulder impingement syndrome, Patient Preference, Covid-19, Public Health, Clinical Decision-Making
- Medical subject headings
- Shoulder Impingement Syndrome, Patient Preference, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in preference to surgery under COVID-19 pandemic.Behavioural
Under the COVID-19 pandemic all arthroscopic procedures were cancelled. We wished to describe if patients experienced a change in preference to surgery under this period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in preference
change of preference for surgery during the waiting period for all planned arthroscopic procedures measured by questionnaire sent by letter asking if patients still want surgery yes or no. No other questions were asked.
Measured: 3 months
Secondary outcomes (1)
Change in preference between groups
difference in preference for surgery between the group of patients planned for arthroscopic procedure in the shoulder and patients planned for arthroscopic procedure in the knee measured by questionnaire sent by letter asking if patients still want surgery yes or no. No other questions were asked..
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start17 Apr 2020
- Primary completion24 Apr 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArthroscopyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Nielsen, Region Zealand
- Investigators
- Jesper S Nielsen, MD, Principal investigator, Zealand University Hospital, Køge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370678
- Sponsor's protocol ID
- ArthrocancellationSUH2020
- Status last verified
- May 2020
- First submitted
- 24 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erratum: Treatments for Shoulder Impingement Syndrome: A PRISMA Systematic Review and Network Meta-Analysis: Erratum. Medicine (Baltimore). 2016 Jun 10;95(23):e96d5. doi: 10.1097/01.md.0000484495.36196.d5. eCollection 2016 Jun.
PubMed 31265590Brignardello-Petersen R, Guyatt GH, Buchbinder R, Poolman RW, Schandelmaier S, Chang Y, Sadeghirad B, Evaniew N, Vandvik PO. Knee arthroscopy versus conservative management in patients with degenerative knee disease: a systematic review. BMJ Open. 2017 May 11;7(5):e016114. doi: 10.1136/bmjopen-2017-016114.
PubMed 28495819Monk AP, Davies LJ, Hopewell S, Harris K, Beard DJ, Price AJ. Surgical versus conservative interventions for treating anterior cruciate ligament injuries. Cochrane Database Syst Rev. 2016 Apr 3;4(4):CD011166. doi: 10.1002/14651858.CD011166.pub2.
PubMed 27039329
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Preference for Surgery of Patients Signed up for Arthroscopic Procedures: COVID-19 Effect on Arthroscopic Patients in a University Hospital in Denmark
- ClinicalTrials.gov ID
- NCT04370678
- Acronym / sponsor ID
- ArthrocancellationSUH2020
- Conditions
- Arthroscopy
- Keywords
- arthroscopy, shoulder impingement syndrome, Patient Preference, Covid-19, Public Health, Clinical Decision-Making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Region ZealandUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 1 May 2020 (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.
This study describes the changes in preference to arthroscopic surgery in two orthopedics departments in Denmark under the COVID-19 pandemic.
Detailed description
Background:
Covid-19 has impacted all aspects of society. In hospitals around the world focus has been on treating the deadly virus, and elective orthopedic surgical procedures has been postponed in Denmark, causing a stop for most arthroscopic procedures for months. It is established that certain conditions leading to arthroscopic orthopedic intervention has fluctuating symptoms symptoms and can have a favorable outcome on conservative treatment. Amongst these conditions who are also treated with non-surgical methods are subacromial decompression impingement[1][1], degenerative knee disease [2] and anterior cruciate ligament injuries[3]. An issue with further understanding the non-surgical effect on this patient group has beencould be reluctance to undergo conservative non-surgical treatment and opt for a surgical treatment. procedure. Because all elective surgery has been postponed in Denmark, and the following longer waiting period for surgery, this has created a unique opportunity to further investigate this patient category.
Aim of study: Investigate the impact of time on waiting list for surgery under COVID-19 pandemic on the preference for surgery in patients planned for arthroscopic surgery.
Discussion The current study will provide information on the change of preferences forto arthroscopic surgery in a patient population who are forced to wait for surgery for a longer period of time, with no possibility of seeking treatment in other hospitals.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients planned for arthroscopic procedures at Zealand University Hospital in Køge in the time period 13-4-20 to 10-5-20.
Key inclusion criteria (2 listed)
- Patients planned for arthroscopic intervention in knee or shoulder.
- Patients seen by an orthopedic surgeon and planned for surgery before 13/3-20
Key exclusion criteria (3 listed)
- Surgery performed in another hospital
- Death
- Emigration
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 |
|---|---|---|
| Change in preference to surgery under COVID-19 pandemic.Under the COVID-19 pandemic all arthroscopic procedures were cancelled. We wished to describe if patients experienced a change in preference to surgery under this period. | Behavioural | – |
Primary outcome
Change in preference
Time frame: 3 months
change of preference for surgery during the waiting period for all planned arthroscopic procedures measured by questionnaire sent by letter asking if patients still want surgery yes or no. No other questions were asked.
1 secondary outcome
Change in preference between groups
Time frame: 3 months
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 7 May 2020.
- Background: PubMed 31265590Erratum: Treatments for Shoulder Impingement Syndrome: A PRISMA Systematic Review and Network Meta-Analysis: Erratum. Medicine (Baltimore). 2016 Jun 10;95(23):e96d5. doi: 10.1097/01.md.0000484495.36196.d5. eCollection 2016 Jun.
- Background: PubMed 28495819Brignardello-Petersen R, Guyatt GH, Buchbinder R, Poolman RW, Schandelmaier S, Chang Y, Sadeghirad B, Evaniew N, Vandvik PO. Knee arthroscopy versus conservative management in patients with degenerative knee disease: a systematic review. BMJ Open. 2017 May 11;7(5):e016114. doi: 10.1136/bmjopen-2017-016114.
- Background: PubMed 27039329Monk AP, Davies LJ, Hopewell S, Harris K, Beard DJ, Price AJ. Surgical versus conservative interventions for treating anterior cruciate ligament injuries. Cochrane Database Syst Rev. 2016 Apr 3;4(4):CD011166. doi: 10.1002/14651858.CD011166.pub2.
- Individual participant dataSharing planned: No
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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.
Jesper S Nielsen, MD principal investigator
Zealand University Hospital, Køge
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 Arthroscopy, run by Region Zealand 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 7 May 2020. 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?
Change in preference (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04370678, which also lists 3 linked publications.
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 7 May 2020.