Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy (BAHA-I)

Pivot Medical

Status

Completed

Conditions

Hip Arthroscopy

Treatments

Device: HipJack Balloon Spacer

Study type

Interventional

Funder types

Industry

Identifiers

NCT01429805

PR01662

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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