Balloon Assisted Hip Arthroscopy - Clinical Evaluation of... | NCT01429805

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

NCT01429805

Sponsor

Pivot Medical Inc.

Status

Completed

Last Update Posted

Jun 20, 2012Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Hip Arthroscopy

Interventions

HipJack Balloon Spacer

Countries

Belgium
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Mar 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Sep 5, 2011

First Submission Date that Met QC Criteria

Sep 6, 2011

First Posted Date

Sep 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2012

Last Update Posted Date

Jun 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Name	Type	Description	Arm Group Labels	Other Names
HipJack Balloon Spacer	Device	Use of the HipJack Kit to maintain distraction of the joint during hip arthroscopy.

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Pellenberg			Belgium
Schulthess Clinic