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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pivot Medical Inc.
ClinicalTrials.gov Identifier:
NCT01429805
First received: September 5, 2011
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Hip Arthroscopy
Device: HipJack Balloon Spacer

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy

Further study details as provided by Pivot Medical Inc.:

Primary Outcome Measures:
  • Ability to access the central compartment of the hip and maintain intra-articular hip joint distraction with the HipJack Balloon Spacer during hip arthroscopy. [ Time Frame: Treatment (Day 0) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in external traction time. [ Time Frame: Treatment (Day 0) ] [ Designated as safety issue: No ]
  • Investigator-related adequacy of central compartment visualization with use of the investigational device. [ Time Frame: Treatment (Day 0) ] [ Designated as safety issue: No ]
  • Investigator-rated adequacy of maneuverability of arthroscopy tools with the investigational device inflated in the central compartment. [ Time Frame: Treatment (Day 0) ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: HipJack Balloon Spacer
    Use of the HipJack Kit to maintain distraction of the joint during hip arthroscopy.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429805

Locations
Belgium
UZ Leuven
Pellenberg, Belgium
Switzerland
Schulthess Clinic
Zurich, Switzerland
United Kingdom
Barts and The London NHS Trust
London, United Kingdom
Sponsors and Collaborators
Pivot Medical Inc.
Investigators
Principal Investigator: Manoj Ramachandran, MD Barts and The London NHS Trust
  More Information

No publications provided

Responsible Party: Pivot Medical Inc.
ClinicalTrials.gov Identifier: NCT01429805     History of Changes
Other Study ID Numbers: PR01662
Study First Received: September 5, 2011
Last Updated: June 19, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Switzerland: Swissmedic
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pivot Medical Inc.:
Hip arthroscopy

ClinicalTrials.gov processed this record on September 18, 2014