Complications Related to Arthroscopic Surgery of the Hip - a Prospective Cohort Study

Femoracetabular Impingement Clinical Trial

Official title:

Complications Related to Arthroscopic Surgery of the Hip - a Prospective Cohort Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02495701
• Other study ID #: 1-16-02-260-15
• Status: Terminated
• Start date: October 1, 2015
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 220
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients undergoing hip arthroscopic surgery at Horsens Hospital, Denmark, during one year.

Exclusion Criteria:

• Non

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Hip Pathology

Intervention

Procedure:
• Hip arthroscopic surgery
Hip arthroscopic surgery

Locations

Country	Name	City	State
Denmark	Horsens Regional Hospital	Horsens

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Horsens Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Park MS, Yoon SJ, Kim YJ, Chung WC. Hip arthroscopy for femoroacetabular impingement: the changing nature and severity of associated complications over time. Arthroscopy. 2014 Aug;30(8):957-63. doi: 10.1016/j.arthro.2014.03.017. Epub 2014 May 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient reported symptoms from the hip	Patients are requested to report if they hear clicks or other sounds from their hip	From surgery to one year after surgery
Other	Treatments of the hip	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
Other	State of the contralateral hip	Patients are asked if they have had surgery or injections of their contralateral hip	From surgery to one year after surgery
Primary	Visual analog scale-pain of the knee		Three months after surgery
Primary	Visual analog scale-pain of the ankle		Three months after surgery
Primary	Number of patients reporting numbness		Three months after surgery
Primary	Number of adverse events	Infections, deep vein thrombosis, caput femoris necrosis, fracture, nerve injuries	From surgery to one year after surgery
Secondary	Visual analog scale-pain of the hip/groin at rest		Two weeks after surgery
Secondary	Visual analog scale-pain of the hip/groin at rest		Three months after surgery
Secondary	Visual analog scale-pain of the hip/groin after activities		Two weeks after surgery
Secondary	Visual analog scale-pain of the hip/groin after activities		Three months after surgery
Secondary	Visual analog scale-pain of the knee		Two weeks after surgery
Secondary	Visual analog scale-pain of the ankle		Two weeks after surgery
Secondary	Number of patients reporting numbness		From surgery to two weeks after surgery
Secondary	Number of patients reporting sexual dysfunction		From surgery to three months after surgery
Secondary	Number of patients and areas where patients report pain (Pain drawings)		Two weeks after surgery
Secondary	Number of patients and areas where patients report pain (Pain drawings)		Three months after surgery
Secondary	Number of patients reporting superficial skin abrasion		From surgery to two weeks after surgery
Secondary	Visual analog scale-pain of the back		Two weeks after surgery
Secondary	Visual analog scale-pain of the back		Three months after surgery