Osteoarthritis ArthritisG7NCT02340390

G7 Acetabular System vs. Exceed ABT Acetabular System in THA

A study testing G7 and Exceed ABT in people with Osteoarthritis Arthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 3 sites in South Korea.

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

Evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Ceramic on Ceramic articulation and Taperloc Complete Microplasty stem compared to patients who received the Exceed ABT Acetabular system with the same combination Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Osteoarthritis Arthritis, Rheumatoid Arthritis
What is being tested?: G7 and Exceed ABT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 3 sitesSouth Korea
Study dates: May 2015to Nov 2018
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision of previously failed total hip arthroplasty.
age over 20 years old

Who cannot join

uncooperative patient or patient with neurologic disorders who are incapable of following directions,
osteoporosis,
metabolic disorders which may impair bone formation,
osteomalacia,
distant foci of infections which may spread to the implant site,
rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
vascular insufficiency, muscular atrophy, or neuromuscular disease.

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

Kyunghee Univ. Hospital
Seoul, 134-727
Samsung Medical Center
Seoul, 135-710
Korea Univ. Hospital
Seoul, 152-703

Other trials in South Korea

About this study

Official title: A PROSPECTIVE MULTI CENTER RANDOMIZED CONTROLLED TRIAL TO EVALUATE G7 Acetabular System With CoC ARTICULATION COMPARED TO EXCEED ABT Acetabular System With CoC ARTICULATION IN TOTAL HIP ARTHROPLASTY

Read the detailed description

This study will be a multi-center randomized controlled study. Eligible patients will be randomly assigned to receive a combination of G7 Acetabular system with CoC articulation and Taperloc Complete Microplasty stem or Exceed ABT Acetabular system with CoC articulation and Taperloc Complete Microplasty stem. Patient demographics, preoperative clinical outcomes, operative information, postoperative clinical outcome, radiographic assessment, incidence of squeaking, incidence of dislocation, implant survivorship and adverse events will be collected prospectively.

Conditions: Osteoarthritis Arthritis, Rheumatoid Arthritis
Being tested: G7, Exceed ABT
Keywords: G7 Acetabular System
Medical subject headings: Joint Diseases, Arthritis, Rheumatoid

What participants receive

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

G7Device
The Biomet G7™ Acetabular System has been designed to provide more options to surgeons for treatment of patients needing total hip arthroplasty, while concurrently simplifying the surgical process with well-designed, modular components and corresponding instruments. The G7™ Acetabular System includes three liner types; ArComXL highly-crosslinked or E-1 Vitamin E-infused polyethylnene and a Biolox Delta (Ceramtec, Plochingen, Germany) ceramic liner.
Exceed ABTDevice
The Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG).

Study groups in NCT02340390
Study group	Role	What they receive
Hip implant1	Experimental	The Biomet G7 Acetabular System is a modular acetabular system, offering two types of acetabular shells. The shells are available in either a solid shell design, with an apical plug, or a limited hole with an apical plug and optional screw holes. Components are available in numerous designs and sizes intended for both primary and/or revision applications. Receives: Device: G7
Hip implant2	Experimental	The Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG). Receives: Device: Exceed ABT

What is being measured

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

the safety and effectiveness of patients (Harris Hip Score)
Harris Hip Score
Measured: 1 year

Secondary outcomes (4)

Gruen zone analysis
Gruen zone analysis of the femoral component and Charnley-DeLee zone analysis of the acetabular system
Measured: Immediate post-op, 6 months, 1 year, 2 year
Loosening on its implant
The presence of signs of loosening on its implant
Measured: Immediate post-op, 6 months, 1 year, 2 year
Squeaking sounds
Number of patients with squeaking Sounds
Measured: 6 months, 1 year, 2 year
Dislocation
Dislocation at different follow-up visits
Measured: 6 months, 1 year, 2 year

Timeline

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

May 2015Nov 2018

First posted16 Jan 2015 (estimated)
Study startMay 2015
Primary completionJun 2016
Study completionNov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteoarthritis ArthritisStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02340390
Sponsor's protocol ID: ORTHO.CR.GH42
Acronym: G7
Status last verified: Mar 2019
First submitted: 8 Jan 2015
Last updated: 26 Mar 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

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 Osteoarthritis Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PROSPECTIVE MULTI CENTER RANDOMIZED CONTROLLED TRIAL TO EVALUATE G7 Acetabular System With CoC ARTICULATION COMPARED TO EXCEED ABT Acetabular System With CoC ARTICULATION IN TOTAL HIP ARTHROPLASTY
ClinicalTrials.gov ID: NCT02340390
Acronym / sponsor ID: G7 / ORTHO.CR.GH42
Conditions: Osteoarthritis Arthritis, Rheumatoid Arthritis
Keywords: G7 Acetabular System
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Jun 2016 (actual)
Study completion: Nov 2018 (actual)
First posted: 16 Jan 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Hip implant1	Experimental	Device: G7The Biomet G7 Acetabular System is a modular acetabular system, offering two types of acetabular shells. The shells are available in either a solid shell design, with an apical plug, or a limited hole with an apical plug and optional screw holes. Components are available in numerous designs and sizes intended for both primary and/or revision applications.
Hip implant2	Experimental	Device: Exceed ABTThe Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG).

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision of previously failed total hip arthroplasty.

Key exclusion criteria (7 listed)

uncooperative patient or patient with neurologic disorders who are incapable of following directions,
osteoporosis,
metabolic disorders which may impair bone formation,
osteomalacia,
distant foci of infections which may spread to the implant site,

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
G7The Biomet G7™ Acetabular System has been designed to provide more options to surgeons for treatment of patients needing total hip arthroplasty, while concurrently simplifying the surgical process with well-designed, modular components and corresponding instruments. The G7™ Acetabular System includes three liner types; ArComXL highly-crosslinked or E-1 Vitamin E-infused polyethylnene and a Biolox Delta (Ceramtec, Plochingen, Germany) ceramic liner.	Device	Hip implant1
Exceed ABTThe Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG).	Device	Hip implant2

Primary outcome

the safety and effectiveness of patients (Harris Hip Score)
Time frame: 1 year
Harris Hip Score

4 secondary outcomes

Gruen zone analysis
Time frame: Immediate post-op, 6 months, 1 year, 2 year
Loosening on its implant
Time frame: Immediate post-op, 6 months, 1 year, 2 year
Squeaking sounds
Time frame: 6 months, 1 year, 2 year
Dislocation
Time frame: 6 months, 1 year, 2 year

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 26 Mar 2019.
Individual participant dataSharing planned: Undecided

Related trials for Osteoarthritis Arthritis

RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
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Osteoarthritis of Knee
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
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Recruiting
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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.

Jung-Joon Yoo, Ph.D principal investigator

Seoul Nat'l Univ. Hospital

Kee-Hyung Rhyu, Ph.D principal investigator

Kyung Hee Uni. Hospital at Gangdong

Seung-Jae Lim, Ph.D principal investigator

Samsung Medical Center

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

Questions about this trial

What is this clinical trial studying?

A study testing G7 and Exceed ABT in people with Osteoarthritis Arthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 3 sites in South Korea.

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 6 inclusion and 7 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 26 Mar 2019. 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 South Korea. 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?

the safety and effectiveness of patients (Harris Hip Score) (time frame: 1 year). 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 NCT02340390.

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 Mar 2019.