Hip Arthroscopy
Conditions
Keywords
Hip arthroscopy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHipJack Balloon Spacer
Use of the HipJack Kit to maintain distraction of the joint during hip arthroscopy.
Sponsors
Pivot Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Scheduled for unilateral arthroscopic procedure of the hip
Exclusion criteria
* Active infection sepsis or osteomyelitis * Body mass index (BMI) of 40 or greater * Open wounds of the hip or leg area * Moderate or severe degenerative hip disease or hip joint space \<3 mm * Large pincer, coxa profunda or protrusio * Retroverted acetabulum * Compromised ligamentum teres or ligamentum teres dysplasia * Previous hip surgery or arthroscopy on the target hip * Hip injury due to high-energy trauma * Hip fracture or hip dislocation on the target hip * Metabolic disorders that may impair bone formation * Osteomalacia or moderate to severe osteoporosis, rapid joint destruction, marked bone loss or bone resorption noted on x-ray * Severe neurosensory deficits * Inadequate joint space distraction with external traction to allow for insertion of HipJack device * Any condition that is a relative or absolute contraindication to hip arthroscopy * Pregnant or lactating * History of venous thrombosis or known coagulopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability to access the central compartment of the hip and maintain intra-articular hip joint distraction with the HipJack Balloon Spacer during hip arthroscopy. | Treatment (Day 0) |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in external traction time. | Treatment (Day 0) |
| Investigator-related adequacy of central compartment visualization with use of the investigational device. | Treatment (Day 0) |
| Investigator-rated adequacy of maneuverability of arthroscopy tools with the investigational device inflated in the central compartment. | 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. | 6 weeks |
Countries
Belgium, Switzerland, United Kingdom
Outcome results
None listed