- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02495701
Complications Related to Arthroscopic Surgery of the Hip - a Prospective Cohort Study
January 23, 2024 updated by: University of Aarhus
Arthroscopic hip surgery is performed with traction on the leg to allow the surgeon to perform the surgical procedure.
A retrospective study has described neuropraxia, ankle joint pain and a skin burn after surgery (1).
Moreover, it has been described that surgeons performing the procedure have a learning curve related to the number of complications described postoperatively.
At the investigators' institution, hip arthroscopies have been performed since 2010 and the 3 surgeons have 4-12 years of experience.
During the past years, changes have been made to secure the best possible comfort for the patient during the arthroscopic procedure.
Hence, there is a rationale for investigating complications after hip arthroscopy in a setting that is less affected by the surgeon's learning curve and with the patient comfort in focus.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Horsens, Denmark, 8700
- Horsens Regional Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing hip arthroscopic surgery at Horsens Hospital, Denmark
Description
Inclusion Criteria:
- All patients undergoing hip arthroscopic surgery at Horsens Hospital, Denmark, during one year.
Exclusion Criteria:
- Non
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Patients having Hip arthroscopic surgery
|
Hip arthroscopic surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale-pain of the knee
Time Frame: Three months after surgery
|
Three months after surgery
|
|
Visual analog scale-pain of the ankle
Time Frame: Three months after surgery
|
Three months after surgery
|
|
Number of patients reporting numbness
Time Frame: Three months after surgery
|
Three months after surgery
|
|
Number of adverse events
Time Frame: From surgery to one year after surgery
|
Infections, deep vein thrombosis, caput femoris necrosis, fracture, nerve injuries
|
From surgery to one year after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual analog scale-pain of the hip/groin at rest
Time Frame: Two weeks after surgery
|
Two weeks after surgery
|
Visual analog scale-pain of the hip/groin at rest
Time Frame: Three months after surgery
|
Three months after surgery
|
Visual analog scale-pain of the hip/groin after activities
Time Frame: Two weeks after surgery
|
Two weeks after surgery
|
Visual analog scale-pain of the hip/groin after activities
Time Frame: Three months after surgery
|
Three months after surgery
|
Visual analog scale-pain of the knee
Time Frame: Two weeks after surgery
|
Two weeks after surgery
|
Visual analog scale-pain of the ankle
Time Frame: Two weeks after surgery
|
Two weeks after surgery
|
Number of patients reporting numbness
Time Frame: From surgery to two weeks after surgery
|
From surgery to two weeks after surgery
|
Number of patients reporting sexual dysfunction
Time Frame: From surgery to three months after surgery
|
From surgery to three months after surgery
|
Number of patients and areas where patients report pain (Pain drawings)
Time Frame: Two weeks after surgery
|
Two weeks after surgery
|
Number of patients and areas where patients report pain (Pain drawings)
Time Frame: Three months after surgery
|
Three months after surgery
|
Number of patients reporting superficial skin abrasion
Time Frame: From surgery to two weeks after surgery
|
From surgery to two weeks after surgery
|
Visual analog scale-pain of the back
Time Frame: Two weeks after surgery
|
Two weeks after surgery
|
Visual analog scale-pain of the back
Time Frame: Three months after surgery
|
Three months after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient reported symptoms from the hip
Time Frame: From surgery to one year after surgery
|
Patients are requested to report if they hear clicks or other sounds from their hip
|
From surgery to one year after surgery
|
Treatments of the hip
Time Frame: From surgery to one year after surgery
|
Patients are asked if they have had further surgery, injections etc. in their operated hip during the past year
|
From surgery to one year after surgery
|
State of the contralateral hip
Time Frame: From surgery to one year after surgery
|
Patients are asked if they have had surgery or injections of their contralateral hip
|
From surgery to one year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
December 15, 2022
Study Completion (Actual)
December 15, 2022
Study Registration Dates
First Submitted
June 1, 2015
First Submitted That Met QC Criteria
July 10, 2015
First Posted (Estimated)
July 13, 2015
Study Record Updates
Last Update Posted (Actual)
January 24, 2024
Last Update Submitted That Met QC Criteria
January 23, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-16-02-260-15
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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