Exceed ABT Acetabular Cup Cementless System

An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet.

Completed

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

Trial summary

A Post-market Clinical Follow-up Study to provide safety, performance and clinical benefits data on the Exceed ABT acetabular cup (implants and instruments) when used in combination with ceramic liners or polyethylene articulating liners bearing Options. A single-center, cohort observational clinical outcomes study Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Rheumatoid Arthritis, Correction of Functional Deformity
How many people: 677 participants
Where: No sites listed yet
Study dates: 1 Jul 2010to 31 Mar 2022
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Male and Female ≥18 years

Who may be able to join

Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program
Patient who gave verbal consent to take part in the study at study commencement and written consent retrospectively at 10 years follow-up by signing the informed consent form according to the General data protection Regulation (GDPR) Patient Consent Form"
Age: => 18 years
Male and Female
Non- inflammatory degenerative joint disease including osteoarthritis, avascular necrosis \& post traumatic arthritis
Rheumatoid arthritis,

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Correction of functional deformity
Revision of failed joint reconstruction or treatment
Treatment of femoral neck and trochanteric fractures of the proximal femur with femoral head involvement and which are unmanageable using other techniques

Who cannot join

Infection, sepsis, and osteomyelitis
Patients who are unwilling or unable to give consent, or to comply with the follow-up program
The patient is known to be pregnant or breastfeeding
Any vulnerable subjects (= individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate)
Uncooperative patient or patient with neurologic disorders who are incapable of fol-lowing instruction
Osteoporosis

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Metabolic disorder which may impair bone formation
Osteomalacia
Local and distant foci of infection
Rapid joint destruction, marked bone loss or bone resorption apparent on roent-genogram
Vascular insufficiency, muscular atrophy, or neuromuscular disease
Skeletal immaturity
Morbid obesity
Foreign body sensitivity. Where suspected, material sensitivity tests are to be made prior to implantation
Any condition that may interfere with the survival of the implant such as Paget's disease, Charcot's disease, sickle cell anaemia or traits, lower extremity muscular atrophy or neuromuscular disease'

About this study

Official title: A Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data on the Exceed ABT Acetabular Cementless Cup System (Implants and Instruments)

A single-center, cohort observational clinical outcomes study

Read the detailed description

Study Aim: To collect survivorship and clinical outcomes long-term data confirm-ing safety, performance and clinical benefits of the Exceed ABT ce-mentless cup when used in combination with ceramic and polyeth-ylene articulating liners

Objectives: Primary Objectives:

Clinical performance - as measured by clinical score data (HHS, WOMAC and Oxford Hip Score), radiographic as-sessments and survivorship which will be based on removal of the device.

Secondary Objectives:

Safety will be evaluated by monitoring incidence of adverse events. Length of study: 13 years (3 years enrollment plus 10 years follow-up): Post-operative follow-up visits at: 1, 3, 5, 7 and 10 years

Conditions: Osteoarthritis, Rheumatoid Arthritis, Correction of Functional Deformity
Medical subject headings: Osteoarthritis, Arthritis, Rheumatoid

What is being measured

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

Harris Hip Score
Clinical performance - as measured by clinical score data (HHS). The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 and a maximum of 100 points.
The scale: Excellent:90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: < 70.
Measured: 10 years
Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score
Clinical performance - as measured by clinical score data - womac pain The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. A higher score indicates a worse clinical outcome.
Womac pain score is reported here.
Measured: 10 years
10 Year Survivorship
Calculated Kaplan-Meier Survivorship based on revision of any component for any reason. Presented as the % of participants with the implant still in place 10 years post-operative.
Measured: 10 years post-operative

Secondary outcomes (1)

Oxford Hip Score
The Oxford hip score (OHS) is self-completion patient-centered outcome measure tool designed to assess disability in patients undergoing total hip replacement. The OHS consists of 12 questions about pain and disability experienced over the past four weeks. Each item has five response categories, given a score of between 1-5 (low disability to high disability). Scoring involves summating the total for each item to produce a final score between 12-60, with a higher score indicating greater disability (old Oxford score).
Measured: 10 years

Timeline

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

1 Jul 201031 Mar 2022

First posted5 Feb 2020
Study start1 Jul 2010
Primary completion28 Feb 2022
Study completion31 Mar 2022

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: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 677 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04255394
Sponsor's protocol ID: BMETEU.CR.EU37
Status last verified: Feb 2024
First submitted: 28 Jan 2020
Last updated: 26 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: 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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data on the Exceed ABT Acetabular Cementless Cup System (Implants and Instruments)
ClinicalTrials.gov ID: NCT04255394
Acronym / sponsor ID: BMETEU.CR.EU37
Conditions: Osteoarthritis, Rheumatoid Arthritis, Correction of Functional Deformity
Study type: Observational
Recruitment status: Completed
Enrolment: 677 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: 1 Jul 2010 (actual)
Primary completion: 28 Feb 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 5 Feb 2020 (actual)
Results: Posted 26 Jul 2024

Clinical summary

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

A single-center, cohort observational clinical outcomes study

Detailed description

Objectives: Primary Objectives:

Clinical performance - as measured by clinical score data (HHS, WOMAC and Oxford Hip Score), radiographic as-sessments and survivorship which will be based on removal of the device.

Secondary Objectives:

Safety will be evaluated by monitoring incidence of adverse events. Length of study: 13 years (3 years enrollment plus 10 years follow-up): Post-operative follow-up visits at: 1, 3, 5, 7 and 10 years

Study design

Observational model: Case-control
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Male and Female ≥18 years

Key inclusion criteria (9 listed)

Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program
Patient who gave verbal consent to take part in the study at study commencement and written consent retrospectively at 10 years follow-up by signing the informed consent form according to the General data protection Regulation (GDPR) Patient Consent Form"
Age: => 18 years
Male and Female
Non- inflammatory degenerative joint disease including osteoarthritis, avascular necrosis \& post traumatic arthritis

Key exclusion criteria (15 listed)

Infection, sepsis, and osteomyelitis
Patients who are unwilling or unable to give consent, or to comply with the follow-up program
The patient is known to be pregnant or breastfeeding
Any vulnerable subjects (= individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate)
Uncooperative patient or patient with neurologic disorders who are incapable of fol-lowing instruction

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Harris Hip Score
Time frame: 10 years
Clinical performance - as measured by clinical score data (HHS). The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 and a maximum of 100 points. The scale: Excellent:90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: < 70.
Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score
Time frame: 10 years
Clinical performance - as measured by clinical score data - womac pain The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. A higher score indicates a worse clinical outcome. Womac pain score is reported here.
10 Year Survivorship
Time frame: 10 years post-operative
Calculated Kaplan-Meier Survivorship based on revision of any component for any reason. Presented as the % of participants with the implant still in place 10 years post-operative.

1 secondary outcome

Oxford Hip Score
Time frame: 10 years

Results and safety

Results posted to the registry on 26 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A MoP	220	38
Group B CoC	457	138

Primary outcome: Harris Hip Score

Time frame: 10 years. Mean (Standard Deviation). Unit: score on a scale

Measure	Group A MoP n = 28	Group B CoC n = 134
Value	89.8 (11.2)	90.4 (13.2)

Primary outcome: Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score

Time frame: 10 years. Mean (Standard Deviation). Unit: score on a scale

Measure	Group A MoP n = 38	Group B CoC n = 148
Value	6.1 (2.5)	6.8 (3.5)

Primary outcome: 10 Year Survivorship

Time frame: 10 years post-operative. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group A MoP n = 208	Group B CoC n = 449
Value	90.47 (84.61 to 96.33)	97.32 (95.42 to 99.23)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All adverse events up to 10 years post-op. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A MoP	63 of 208 (30.3%)	1 of 208 (0.5%)	36 of 208
Group B CoC	89 of 449 (19.8%)	2 of 449 (0.4%)	25 of 449

Limitations and caveats (from the sponsor): Initial CRF in the study did not record if an adverse event was serious yes/no. Where unknown, the event is recorded as serious.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
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Not yet 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.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet.

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 9 inclusion and 15 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 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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 26 Jul 2024). 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: 10 years). The study lists 3 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 NCT04255394.

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 Jul 2024.