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

Hip Arthroscopy Clinical Trial

— BAHA-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429805
• Other study ID #: PR01662
• Status: Completed
• Phase: N/A
• First received: September 5, 2011
• Last updated: June 19, 2012
• Start date: September 2011
• Est. completion date: April 2012

Study information

• Verified date: June 2012
• Source: Pivot Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencySwitzerland: SwissmedicBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hip Arthroscopy

Intervention

Device:
• HipJack Balloon Spacer
Use of the HipJack Kit to maintain distraction of the joint during hip arthroscopy.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Pellenberg
Switzerland	Schulthess Clinic	Zurich
United Kingdom	Barts and The London NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Pivot Medical Inc.

Countries where clinical trial is conducted

Belgium,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Reduction in external traction time.		Treatment (Day 0)	No
Secondary	Investigator-related adequacy of central compartment visualization with use of the investigational device.		Treatment (Day 0)	No
Secondary	Investigator-rated adequacy of maneuverability of arthroscopy tools with the investigational device inflated in the central compartment.		Treatment (Day 0)	No
Secondary	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	Yes