Degenerative Joint DiseaseNCT02543437

Large Head X3 Study

A study testing Trident Acetabular X3 Insert in people with Degenerative Joint Disease, run by Stryker Japan K.K. at 4 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to explore the benefit of X3 polyethlene inserts with larger diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the Stryker computerized tomography (CT) based… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Degenerative Joint Disease
What is being tested?: Trident Acetabular X3 Insert
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 4 sitesJapan
Study dates: Jul 2010to Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient who is a candidate for primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
Patient who has diagnosis of degenerative joint disease and no bacterial infectious disease.
Patient whose age is 20 or over.
Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
Patient who is willing and able to comply with postoperative scheduled evaluations.

Who cannot join

Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
Patient who requires revision surgery of a previously implanted total hip arthroplasty.
Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 45.
Patient who is or may be pregnant female.
Patient who has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
Patient who is immunologically suppressed or receiving chronic steroids.
Patient who is judged ineligible with specific reason by primary doctor.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

Nagoya Kyoritsu Hospital
Nagoya, Aichi-ken, 454-0933
Osaka City General Hospital.
Osaka, 534-0021
Kyowakai Hospital.
Suita, Osaka, 564-0001
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004

Other trials in Japan

About this study

Official title: The Effect of Large Diameter Head to Prevent Dislocation, and of 3 rd Generation Highly Crosslinked Polyethylene to Reduce Wear in Computer Assisted Total Hip Arthroplasty.

Conditions: Degenerative Joint Disease
Being tested: Trident Acetabular X3 Insert
Medical subject headings: Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trident Acetabular X3 InsertDevice

Study groups in NCT02543437
Study group	Role	What they receive
Trident Acetabular X3 Insert	Other	28mm, 32mm and 36mm liner Receives: Device: Trident Acetabular X3 Insert

What is being measured

The primary outcome is the main question the study is designed to answer.

Range of Motion(ROM) (Degree)
Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.
Measured: Intraoperative
Lift Off Distance in Dislocation Maneuver(mm)
Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.
Measured: Intraoperative

Secondary outcomes (1)

Wear Rate(%)
Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert.
Measured: 1 year, 2 years, 3 years and 5 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Jul 2019

First posted7 Sep 2015 (estimated)
Study startJul 2010
Primary completionDec 2011
Study completionJul 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Degenerative Joint DiseaseStudies 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02543437
Sponsor's protocol ID: SJCR-OR-1002
Status last verified: Sep 2018
First submitted: 10 Aug 2015
Last updated: 15 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Large Diameter Head to Prevent Dislocation, and of 3 rd Generation Highly Crosslinked Polyethylene to Reduce Wear in Computer Assisted Total Hip Arthroplasty.
ClinicalTrials.gov ID: NCT02543437
Acronym / sponsor ID: SJCR-OR-1002
Conditions: Degenerative Joint Disease
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (actual)
Lead sponsor: Stryker Japan K.K.Industry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Dec 2011 (actual)
Study completion: Jul 2019 (estimated)
First posted: 7 Sep 2015 (estimated)
Results: Posted 6 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Trident Acetabular X3 Insert	Other	Device: Trident Acetabular X3 Insert28mm, 32mm and 36mm liner

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient who is a candidate for primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
Patient who has diagnosis of degenerative joint disease and no bacterial infectious disease.
Patient whose age is 20 or over.
Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
Patient who is willing and able to comply with postoperative scheduled evaluations.

Key exclusion criteria (8 listed)

Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
Patient who requires revision surgery of a previously implanted total hip arthroplasty.
Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 45.
Patient who is or may be pregnant female.
Patient who has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.

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
Trident Acetabular X3 Insert	Device	Trident Acetabular X3 Insert

Primary outcome

Range of Motion(ROM) (Degree)
Time frame: Intraoperative
Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.
Lift Off Distance in Dislocation Maneuver(mm)
Time frame: Intraoperative
Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.

1 secondary outcome

Wear Rate(%)
Time frame: 1 year, 2 years, 3 years and 5 years after surgery

Results and safety

Results posted to the registry on 6 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trident Acetabular X3 Insert	117	117

Primary outcome: Range of Motion(ROM) (Degree)

Time frame: Intraoperative. Mean (Standard Deviation). Unit: Degree

Measure	X3 Liner n = 117
Maximam Flexion	2.6 (4.5)
Maximam Extension	2.6 (4.7)
Maximam Abduction	2.6 (4.5)

Population analysed: Comparison between 28mm liner and 36mm line. Participants with available data : 119 hips in 117 participants.

Primary outcome: Lift Off Distance in Dislocation Maneuver(mm)

Time frame: Intraoperative. Mean (Standard Deviation). Unit: mm

Measure	X3 Liner n = 100
Cup inclination	-0.2 (3.5)
Cup anteversion	1.4 (5.3)
Stem anteversion	-1.2 (6.4)

Population analysed: participants with available data : 100 hips in 100 participants.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
X3 Liner	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Trident Acetabular X3 Insert in people with Degenerative Joint Disease, run by Stryker Japan K.K. at 4 sites in Japan.

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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 6 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Range of Motion(ROM) (Degree) (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02543437.

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 15 Oct 2018.