Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy

Conditions
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Hip Arthroscopy

Intervention / Treatment
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* Device: HipJack Balloon Spacer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: HipJack Balloon Spacer|Use of the HipJack Kit to maintain distraction of the joint during hip arthroscopy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip arthroscopy