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OpenTrials
Completed

NCT Number: NCT01429805

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven, Pellenberg, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HipJack Balloon Spacer

Device

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

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.

    Time frame: Treatment (Day 0)

Secondary outcomes

  1. Reduction in external traction time.

    Time frame: Treatment (Day 0)

  2. Investigator-related adequacy of central compartment visualization with use of the investigational device.

    Time frame: Treatment (Day 0)

  3. Investigator-rated adequacy of maneuverability of arthroscopy tools with the investigational device inflated in the central compartment.

    Time frame: Treatment (Day 0)

  4. 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

Sponsors and collaborators

Lead sponsor

Pivot Medical Inc.

Industry

Registry information

Acronym: BAHA-I

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2011
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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