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Clinical Trials/NCT02495701
NCT02495701TerminatedNot Applicable

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

University of Aarhus1 site in 1 country220 target enrollmentStarted: October 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
220
Locations
1
Primary Endpoint
Visual analog scale-pain of the knee

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Visual analog scale-pain of the knee

Time Frame: Three months after surgery

Visual analog scale-pain of the ankle

Time Frame: Three months after surgery

Number of patients reporting numbness

Time Frame: 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

Secondary Outcomes

  • Number of patients reporting superficial skin abrasion(From surgery to two weeks after surgery)
  • Visual analog scale-pain of the hip/groin at rest(Three months after surgery)
  • Visual analog scale-pain of the hip/groin after activities(Three months after surgery)
  • Visual analog scale-pain of the knee(Two weeks after surgery)
  • Visual analog scale-pain of the ankle(Two weeks after surgery)
  • Number of patients reporting numbness(From surgery to two weeks after surgery)
  • Number of patients reporting sexual dysfunction(From surgery to three months after surgery)
  • Number of patients and areas where patients report pain (Pain drawings)(Three months after surgery)
  • Visual analog scale-pain of the back(Three months after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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