- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04370678
Changes in Preference for Surgery of Patients Signed up for Arthroscopic Procedures
Changes in Preference for Surgery of Patients Signed up for Arthroscopic Procedures: COVID-19 Effect on Arthroscopic Patients in a University Hospital in Denmark
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zealand Region
-
Køge, Zealand Region, Denmark, 4600
- Zealand University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients planned for arthroscopic intervention in knee or shoulder.
- Patients seen by an orthopedic surgeon and planned for surgery before 13/3-20
Exclusion Criteria:
- Surgery performed in another hospital
- Death
- Emigration
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preference between groups
Time Frame: 3 months
|
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..
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jesper S Nielsen, MD, Zealand University Hospital, Køge
Publications and helpful links
General 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.
- Brignardello-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.
- Monk 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ArthrocancellationSUH2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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