Arthroplasty, Replacement, HipNCT00960206

ABC/Trident® Ceramic Post Approval Study

A study testing Trident® Ceramic Insert/Trident® AD HA Acetabular Shell, Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell and OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application. Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Arthroplasty, Replacement, Hip
What is being tested?: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell, Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell and OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 413 participants
Where: 6 sitesUnited States
Study dates: Mar 2003to Oct 2010
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 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The individual has signed a Patient Informed Consent (PIC), specific to this study, and approved by the Institutional Review Board (IRB).
The individual is between the ages of 21 and 75 years.
The individual is not classified as morbidly obese.
The individual clinically qualifies for total hip arthroplastic surgery based on physical examination and medical history.
The individual is diagnosed with a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant).
The individual does not have an active infection within the affected hip joint.

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The individual has not had a previous total hip replacement or hip fusion to the affected hip joint.
The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse).
The individual does not have a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the device.
The individual does not have a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is not immunologically suppressed, nor receiving steroids in excess of physiologic dose requirements.
The individual is skeletally mature.
The individual is not pregnant.
The individual is not a prisoner.
The individual has no plans to relocate to another geographic area before the completion of the study.

Who cannot join

None listed.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Emory Univeristy
Atlanta, Georgia, 30329
Orthopaedic Surgery Associates
Boca Raton, Florida, 33435
New England Baptist Hospital
Boston, Massachusetts, 02120
Indiana University
Indianapolis, Indiana, 46202
Greater Pittsburgh Orthopaedics Assoc.
Moon Township, Pennsylvania, 15108
Toledo Joint Replacement and Orthopedic Center
Toledo, Ohio, 43623

Other trials in United States

About this study

Official title: Post-Approval Study of the ABC and Trident® Systems

Read the detailed description

The ABC/ Trident® study was initiated in 1996 as an FDA IDE pre-market study in the United States for alumina bearing THR. PreMarket Approval (PMA)application was approved in February 3,2003. The Post Approval Study (PAS) involved six surgeon investigators from the original IDE study. Subjects who consented to participate in the Post Approval Study continued to be followed to collect limited patient reported data regarding status of the hip.

Conditions: Arthroplasty, Replacement, Hip
Being tested: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell, Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell, OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

What participants receive

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

Trident® Ceramic Insert/Trident® AD HA Acetabular ShellDevice
Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular ShellDevice
Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular ShellDevice
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

Study groups in NCT00960206
Study group	Role	What they receive
Trident®System	Experimental	Trident® Ceramic Insert/Trident® AD HA Acetabular Shell Receives: Device: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
ABC System	Experimental	Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell Receives: Device: Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
Control	Active comparator	OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell Receives: Device: OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

What is being measured

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

Component Revision and Complications
The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.
Measured: 10 years

Secondary outcomes (3)

Harris Hip Score
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.
90 - 100 = excellent
80 - 89 = good
70 - 79 = fair
0 - 69 = poor
Measured: 3-5 and 10 Years
Radiographic Evaluation
Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm.
Measured: 3-5 and 10 years
Hip Follow-Up Questionnaire
A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as "satisfied" below); whether they have any study hip pain (noted as "no pain" below); and whether they have had any surgery on the study hip during the previous year noted as "no surgery" below).
Measured: 6-10 years

Timeline

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

Mar 2003Oct 2010

First posted17 Aug 2009 (estimated)
Study startMar 2003
Primary completionOct 2010
Study completionOct 2010

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 Arthroplasty, Replacement, HipStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 413 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00960206
Sponsor's protocol ID: 33/45
Status last verified: Dec 2016
First submitted: 5 Aug 2009
Last updated: 3 Feb 2017
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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All Arthroplasty, Replacement, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-Approval Study of the ABC and Trident® Systems
ClinicalTrials.gov ID: NCT00960206
Acronym / sponsor ID: 33/45
Conditions: Arthroplasty, Replacement, Hip
Study type: Interventional
Recruitment status: Completed
Enrolment: 413 participants (actual)
Lead sponsor: Stryker OrthopaedicsIndustry (pharma, biotech, devices)
Study start: Mar 2003
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 17 Aug 2009 (estimated)
Results: Posted 15 Aug 2014

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Trident®System	Experimental	Device: Trident® Ceramic Insert/Trident® AD HA Acetabular ShellTrident® Ceramic Insert/Trident® AD HA Acetabular Shell
ABC System	Experimental	Device: Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular ShellAlumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
Control	Active comparator	Device: OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular ShellOmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

The individual has signed a Patient Informed Consent (PIC), specific to this study, and approved by the Institutional Review Board (IRB).
The individual is between the ages of 21 and 75 years.
The individual is not classified as morbidly obese.
The individual clinically qualifies for total hip arthroplastic surgery based on physical examination and medical history.
The individual is diagnosed with a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant).

Key exclusion criteria (0 listed)

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® Ceramic Insert/Trident® AD HA Acetabular ShellTrident® Ceramic Insert/Trident® AD HA Acetabular Shell	Device	Trident®System
Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular ShellAlumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell	Device	ABC System
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular ShellOmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell	Device	Control

Primary outcome

Component Revision and Complications
Time frame: 10 years
The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.

3 secondary outcomes

Harris Hip Score
Time frame: 3-5 and 10 Years
Radiographic Evaluation
Time frame: 3-5 and 10 years
Hip Follow-Up Questionnaire
Time frame: 6-10 years

Results and safety

Results posted to the registry on 15 Aug 2014, 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® System	190	150
ABC System	185	158
Control	89	77

Primary outcome: Component Revision and Complications

Time frame: 10 years. Number. Unit: hips

Measure	Trident® System n = 177	ABC System n = 166	Control n = 87
Value	2	2	2

ABC System vs Control: p = 0.0832, Log Rank
Trident® System vs Control: p = 0.1657, Log Rank

Population analysed: Number of participants analyzed includes all subjects enrolled.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trident® System	1 of 190 (0.5%)	36 of 190 (18.9%)	Not reported
ABC System	1 of 185 (0.5%)	17 of 185 (9.2%)	Not reported
Control	1 of 89 (1.1%)	7 of 89 (7.9%)	Not reported
All Participants	1 of 413 (0.2%)	0 of 413 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroplasty, Replacement, Hip

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Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
RecruitingPhase 4
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RecruitingObservational study
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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.

William Capello, MD study chair

Indiana University Medical Center

Benjamin Bierbaum, MD principal investigator

New England Baptist Hospital

James D'Antonio, MD study chair

Greater Pittsburgh Orthopaedic Associates

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

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 0 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 15 Aug 2014). 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?

Component Revision and Complications (time frame: 10 years). 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 NCT00960206.

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 3 Feb 2017.