OsteoarthritisPhase 4NCT00715026

Trilogy AB Acetabular Hip System Post Approval Study

A Phase 4 study testing Trilogy AB Acetabular Hip Implant System in people with Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a post-approval study with prospective enrollment in the United States and a retrospective enrollment outside the United States to obtain functional, quality of life and radiographic data, which will facilitate assessment of the clinical performance of the Zimmer Trilogy AB Acetabular Hip System. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia
What is being tested?: Trilogy AB Acetabular Hip Implant System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 2 sitesUnited States
Study dates: Apr 2009to Jun 2012
Phase: Phase 4
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Non-obese patients
The patient is a good candidate for a primary hip arthroplasty using the Zimmer Trilogy AB Acetabular Hip System.
Patient is willing and able to give informed consent to participate in the follow-up program.
Patient is suitable for surgery and able to participate in the follow-up program.

Who cannot join

Skeletally immature
Rheumatoid arthritis
Osteoradionecrosis
Infection
Nerve or muscle disease that may have a negative affect on gait or weight bearing
Loss of abductor musculature in the affected limb

Show all 16Show fewer

Poor bone stock
Poor skin coverage around the hip joint
Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray
Previous total or cemented hemi-arthroplasty of the affected hip
Previous pinning or plating of the affected hip
Patients with heavy labor jobs or extreme activity levels
Patients who participate in sports activities or require deep flexion
Patients who are obese
Patients who have other disabilities
Patients who are unwilling or unable to give consent, or to comply with the protocol and follow-up program.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Shrock Orthopedic Research
Fort Lauderdale, Florida, 33136
University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Multicenter Post Approval Study of the Trilogy AB(R) Acetabular System

Read the detailed description

To obtain functional, quality of life and radiographic data to evaluate the clinical performance of the Zimmer Trilogy AB Acetabular Hip System in primary total hip replacement surgery.

Conditions: Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia, Traumatic Arthritis
Being tested: Trilogy AB Acetabular Hip Implant System
Keywords: Arthritis, Total Hip, Ceramic, Hip Replacement, Total Hip Arthroplasty (THA), Joint Disease
Medical subject headings: Osteoarthritis, Osteonecrosis, Hip Dislocation, Congenital, Arthritis, Joint Diseases

What participants receive

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

Trilogy AB Acetabular Hip Implant SystemDevice
Total hip replacement with ceramic on ceramic treatment surfaces.

Study groups in NCT00715026
Study group	Role	What they receive
Trilogy AB Acetabular Hip Implant System	Other	Post Approval Study of Device. Receives: Device: Trilogy AB Acetabular Hip Implant System

What is being measured

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

Harris Hip Score
The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.
Measured: Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years

Secondary outcomes (1)

Continued Assessment of Implant Survivorship and Incidences of Adverse Events.
A total of 37 Adverse Events were reported. There have been no UADEs reported in this study population. At the time of site closure all AEs were resolved or tolerated. Implant survivorship not reportable due to early study termination.
Measured: At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years

Timeline

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

Apr 2009Jun 2012

First posted15 Jul 2008 (estimated)
Study startApr 2009
Primary completionJun 2012
Study completionJun 2012

Why it stopped: Sponsor business decision unrelated to clinical performance.

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 OsteoarthritisStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00715026
Sponsor's protocol ID: 06-300
Other IDs: 06-300, Revised 3-1-2010
Status last verified: Nov 2014
First submitted: 8 Jul 2008
Last updated: 26 Nov 2014
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

Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Post Approval Study of the Trilogy AB(R) Acetabular System
ClinicalTrials.gov ID: NCT00715026
Acronym / sponsor ID: 06-300
Conditions: Osteoarthritis, Avascular Necrosis, Congenital Hip Dysplasia, Traumatic Arthritis
Keywords: Arthritis, Total Hip, Ceramic, Hip Replacement, Total Hip Arthroplasty (THA), Joint Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor business decision unrelated to clinical performance.
Enrolment: 31 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 15 Jul 2008 (estimated)
Results: Posted 26 Nov 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

To obtain functional, quality of life and radiographic data to evaluate the clinical performance of the Zimmer Trilogy AB Acetabular Hip System in primary total hip replacement surgery.

Study design

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

Arm	Type	Receives
Trilogy AB Acetabular Hip Implant System	Other	Device: Trilogy AB Acetabular Hip Implant SystemPost Approval Study of Device.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Non-obese patients
The patient is a good candidate for a primary hip arthroplasty using the Zimmer Trilogy AB Acetabular Hip System.
Patient is willing and able to give informed consent to participate in the follow-up program.
Patient is suitable for surgery and able to participate in the follow-up program.

Key exclusion criteria (16 listed)

Skeletally immature
Rheumatoid arthritis
Osteoradionecrosis
Infection
Nerve or muscle disease that may have a negative affect on gait or weight bearing

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
Trilogy AB Acetabular Hip Implant SystemTotal hip replacement with ceramic on ceramic treatment surfaces.	Device	Trilogy AB Acetabular Hip Implant System

Primary outcome

Harris Hip Score
Time frame: Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years
The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent.

1 secondary outcome

Continued Assessment of Implant Survivorship and Incidences of Adverse Events.
Time frame: At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years

Results and safety

Results posted to the registry on 26 Nov 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
Trilogy AB Acetabular Hip Implant System	31	21

Primary outcome: Harris Hip Score

Time frame: Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years. Mean (Standard Deviation). Unit: units on a scale

Measure	Trilogy AB Acetabular Hip Implant System n = 24
Preop Harris Hip Scores	52.7 (11.6)
3 Months Harris Hip Score	68.2 (16.11)
1 Year Harris Hip Scores	70 (19.54)

Population analysed: Data was received on 24 subjects/25 hips at preop, on 17 subjects/18 hips at 3 months, and on 4 subjects at 1 year prior to the early termination of the study. Each hip, whether unilateral or bilateral, was counted separately. Early study termination was done due to voluntary removal of the device from the US market.

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
Trilogy AB Acetabular Hip Implant System	6 of 25 (24%)	14 of 25 (56%)	Not reported

Limitations and caveats (from the sponsor): A business decision unrelated to device performance led to the early termination of the study and withdrawal of the study device(s) from the US market. Early termination of the study limits the usefulness of the available data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis

Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

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.

Kevin Schrock, MD principal investigator

Schrock Orthopedic Research

Gwo-Chin Lee, MD principal investigator

University of Pennsylvania/Penn Presbyterian Hospital

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trilogy AB Acetabular Hip Implant System in people with Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 2 sites in United States.

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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 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?

Harris Hip Score (time frame: Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 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 NCT00715026.

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 26 Nov 2014.