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

NCT01429805 | Completed

• 1 other identifier: PR01662
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 3

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.

Conditions

Hip Arthroscopy

Keywords

Hip arthroscopy

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• 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

Interventions

HipJack Balloon Spacer DEVICE

Use of the HipJack Kit to maintain distraction of the joint during hip arthroscopy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Scheduled for unilateral arthroscopic procedure of the hip

You may not qualify if:

• 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

Sponsors & Collaborators

• Pivot Medical Inc.: lead

Study Sites (3)

UZ Leuven

Pellenberg, Belgium

Location

Schulthess Clinic

Zurich, Switzerland

Location

Barts and The London NHS Trust

London, United Kingdom

Location

Study Officials

• Manoj Ramachandran, MD

  Barts and The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2011
• First Posted: September 7, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

GB (1); BE (1); CH (1)