Clinical trial NCT02495701: Complications Related to Arthroscopic Surgery of the Hip - a Prospective Cohort Study
Official title: Complications Related to Arthroscopic Surgery of the Hip - a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hip Pathology
Femoracetabular Impingement
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Horsens Hospital
First posted: 2015-07-13
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing hip arthroscopic surgery at Horsens Hospital, Denmark

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Non

Primary outcomes:
measure: Visual analog scale-pain of the knee
timeFrame: Three months after surgery
measure: Visual analog scale-pain of the ankle
timeFrame: Three months after surgery
measure: Number of patients reporting numbness
timeFrame: Three months after surgery
measure: Number of adverse events
timeFrame: From surgery to one year after surgery
Secondary outcomes:
measure: Visual analog scale-pain of the hip/groin at rest
timeFrame: Two weeks after surgery
measure: Visual analog scale-pain of the hip/groin at rest
timeFrame: Three months after surgery
measure: Visual analog scale-pain of the hip/groin after activities
timeFrame: Two weeks after surgery
measure: Visual analog scale-pain of the hip/groin after activities
timeFrame: Three months after surgery
measure: Visual analog scale-pain of the knee
timeFrame: Two weeks after surgery
measure: Visual analog scale-pain of the ankle
timeFrame: Two weeks after surgery
measure: Number of patients reporting numbness
timeFrame: From surgery to two weeks after surgery
measure: Number of patients reporting sexual dysfunction
timeFrame: From surgery to three months after surgery
measure: Number of patients and areas where patients report pain (Pain drawings)
timeFrame: Two weeks after surgery
measure: Number of patients and areas where patients report pain (Pain drawings)
timeFrame: Three months after surgery
measure: Number of patients reporting superficial skin abrasion
timeFrame: From surgery to two weeks after surgery
measure: Visual analog scale-pain of the back
timeFrame: Two weeks after surgery
measure: Visual analog scale-pain of the back
timeFrame: Three months after surgery
Other outcomes:
measure: Patient reported symptoms from the hip
timeFrame: From surgery to one year after surgery
measure: Treatments of the hip
timeFrame: From surgery to one year after surgery
measure: State of the contralateral hip
timeFrame: From surgery to one year after surgery
Locations:
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
Study officials:
References:
citation: 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.