Status:
COMPLETED
Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy
Lead Sponsor:
Pivot Medical Inc.
Conditions:
Hip Arthroscopy
Eligibility:
All Genders
18+ years
Phase:
NA
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 distracti...
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.
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Scheduled for unilateral arthroscopic procedure of the hip
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01429805
Start Date
September 1 2011
End Date
April 1 2012
Last Update
June 20 2012
Active Locations (3)
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1
UZ Leuven
Pellenberg, Belgium
2
Schulthess Clinic
Zurich, Switzerland
3
Barts and The London NHS Trust
London, United Kingdom