The purpose of this study is to obtain information on the safety and performance of HipJack Balloon Spacer to access the central compartment of the hip and maintain intra-articular hip joint distraction during arthroscopy of the central compartment of the hip.
The HipJack Kit is intended to maintain distraction of the joint during hip arthroscopy. This study will evaluate the Kit in clinical sites outside of the United States.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Use of the HipJack Kit to maintain distraction of the joint during hip arthroscopy.
UZ Leuven
Pellenberg, Belgium
Schulthess Clinic
Zurich, Switzerland
Barts and The London NHS Trust
London, United Kingdom
Ability to access the central compartment of the hip and maintain intra-articular hip joint distraction with the HipJack Balloon Spacer during hip arthroscopy.
Time frame: Treatment (Day 0)
Reduction in external traction time.
Time frame: Treatment (Day 0)
Investigator-related adequacy of central compartment visualization with use of the investigational device.
Time frame: Treatment (Day 0)
Investigator-rated adequacy of maneuverability of arthroscopy tools with the investigational device inflated in the central compartment.
Time frame: Treatment (Day 0)
The occurrence of serious adverse events by 6-week follow-up rated by the investigator to be probably or definitely related to the investigational device.
Time frame: 6 weeks
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