Clinical trial NCT01429805: Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy
Official title: Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthroscopy
Keywords: Hip arthroscopy
Lead sponsor: Pivot Medical Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ability to access the central compartment of the hip and maintain intra-articular hip joint distraction with the HipJack Balloon Spacer during hip arthroscopy.
timeFrame: Treatment (Day 0)
Secondary outcomes:
measure: Reduction in external traction time.
timeFrame: Treatment (Day 0)
measure: Investigator-related adequacy of central compartment visualization with use of the investigational device.
timeFrame: Treatment (Day 0)
measure: Investigator-rated adequacy of maneuverability of arthroscopy tools with the investigational device inflated in the central compartment.
timeFrame: Treatment (Day 0)
measure: 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.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: UZ Leuven
city: Zurich
country: Switzerland
facility: Schulthess Clinic
city: London
country: United Kingdom
facility: Barts and The London NHS Trust
Study officials:
affiliation: Barts and The London NHS Trust
name: Manoj Ramachandran, MD
role: PRINCIPAL_INVESTIGATOR
References: