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

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.

Study Overview

• Status: Completed
• Conditions: Hip Arthroscopy
• Intervention / Treatment: Device: HipJack Balloon Spacer

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Pellenberg, Belgium
    • UZ Leuven
• Switzerland
  • Zurich, Switzerland
    • Schulthess Clinic
• United Kingdom
  • London, United Kingdom
    • Barts and the London NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pivot Medical Inc.
• Investigators: Principal Investigator: Manoj Ramachandran, MD, Barts and the London NHS Trust

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: September 5, 2011
• First Submitted That Met QC Criteria: September 6, 2011
• First Posted (Estimate): September 7, 2011

Study Record Updates

• Last Update Posted (Estimate): June 20, 2012
• Last Update Submitted That Met QC Criteria: June 19, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Hip arthroscopy
• Other Study ID Numbers: PR01662