Hip ArthroscopyBAHA-INCT01429805
Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy
A study testing HipJack Balloon Spacer in people with Hip Arthroscopy, run by Pivot Medical Inc. at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthroscopy
- What is being tested?
- HipJack Balloon Spacer
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Scheduled for unilateral arthroscopic procedure of the hip
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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.
Read the 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.
- Conditions
- Hip Arthroscopy
- Being tested
- HipJack Balloon Spacer
- Keywords
- Hip arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HipJack Balloon SpacerDevice
Use of the HipJack Kit to maintain distraction of the joint during hip arthroscopy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to access the central compartment of the hip and maintain intra-articular hip joint distraction with the HipJack Balloon Spacer during hip arthroscopy.
Measured: Treatment (Day 0)
Secondary outcomes (4)
Reduction in external traction time.
Measured: Treatment (Day 0)
Investigator-related adequacy of central compartment visualization with use of the investigational device.
Measured: Treatment (Day 0)
Investigator-rated adequacy of maneuverability of arthroscopy tools with the investigational device inflated in the central compartment.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pivot Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manoj Ramachandran, MD, Principal investigator, Barts and The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429805
- Sponsor's protocol ID
- PR01662
- Acronym
- BAHA-I
- Status last verified
- Jun 2012
- First submitted
- 5 Sep 2011
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT01429805
- Acronym / sponsor ID
- BAHA-I / PR01662
- Conditions
- Hip Arthroscopy
- Keywords
- Hip arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pivot Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Scheduled for unilateral arthroscopic procedure of the hip
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HipJack Balloon SpacerUse of the HipJack Kit to maintain distraction of the joint during hip arthroscopy. | Device | – |
Primary outcome
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)
4 secondary outcomes
Reduction in external traction time.
Time frame: Treatment (Day 0)
Investigator-related adequacy of central compartment visualization with use of the investigational device.
Time frame: Treatment (Day 0)
Investigator-rated adequacy of maneuverability of arthroscopy tools with the investigational device inflated in the central compartment.
Time frame: 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.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj Ramachandran, MD principal investigator
Barts and The London NHS Trust
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HipJack Balloon Spacer in people with Hip Arthroscopy, run by Pivot Medical Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012; AzTrials last refreshed its copy on 7 Nov 2026.