Osteoarthritis, HipNCT04079127

Avenir Müller Hip Stem Post Market Surveillance Study

An observational study of Osteoarthritis, Hip 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.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip
What is being tested?: Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.
Type of treatment: Medical device
How many people: 150 participants
Where: No sites listed yet
Study dates: 9 Jan 2010to 31 Aug 2019
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: Patients suffering from severe hip pain and disability requiring a total hip arthroplasty.

Who may be able to join

Patients able to participate in a follow-up program based upon physical examination and medical history.
Patients or patient's legal representatives who have given written consent to take part in the study by signing the 'Patient Consent Form'.
18 years minimum.
Male and female.
Baseline data exist (pre-, peri- and immediate postoperative)

Who cannot join

Patients who are unwilling or unable to comply with the follow-up program.
Known pregnancy.
Patients who are skeletally immature.

About this study

Official title: A Multi-centre, Non-comparative, Retrospective Post-market Surveillance Study to Obtain Clinical Outcomes Data on the Zimmer Avenir Müller Hip Stem

This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Avenir Müller Hip Stem.

Read the detailed description

The objective of this post market surveillance study is to obtain outcome data on the Avenir Müller Hip Stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant.

This is a multi-centre, retrospective post-market surveillance study involving orthopaedic surgeons skilled in hip surgery. Each case enrolled has received the Avenir Müller Hip Stem for a primary hip arthroplasty. The Avenir Müller Hip Stem is CE marked (European Conformity) and commercially available.

Conditions: Osteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip, Dislocated Hip, Osteonecrosis, Post-traumatic; Arthrosis
Being tested: Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.
Medical subject headings: Osteoarthritis, Hip, Arthritis, Rheumatoid, Hip Fractures, Hip Dislocation, Osteonecrosis, Osteoarthritis

What participants receive

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

Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.Device
Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.

Study groups in NCT04079127
Study group	Role	What they receive
Patients suffering from severe hip pain and disability		Patients in need of a total hip arthroplasty. Receives: Device: Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.

What is being measured

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

Evaluation of Pain and Functional Performance Determined by the Harris Hip Score
The Harris Hip Score is a questionnaire filled by the surgeon with the patient who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication.
The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction.
There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Measured: 10 years

Secondary outcomes (2)

Confirmation of Safety Based on Complications
Number of patients with adverse events related to the implant will be reported. Adverse events include: dislocations of the hip, revisions and removals of the implant components.
Here, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the complications occured from the early stages of the study, and up to 10 year post surgery, and could occur to any patients.
Measured: up to 10 years
Survivorship of the Implant
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Here, the entire cohort of patients (and hips) enrolled in the study were considered and are reported as the revisions could happen from the early stages of the study, and up to 10 year post surgery, and could occur to any patients. Even if a patient did not come back for a visit, the information if the implant was still in place was provided and taken into account for the survival analysis (gives higher numbers than for the clinical evaluation).
Measured: 10 years

Timeline

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

9 Jan 201031 Aug 2019

First posted6 Sep 2019
Study start9 Jan 2010
Primary completion29 Jun 2019
Study completion31 Aug 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis, HipStudies 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: Cohort
Time perspective: Other
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04079127
Sponsor's protocol ID: 09H08
Status last verified: Apr 2021
First submitted: 2 Sep 2019
Last updated: 14 May 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
Individual data sharing: No

Publications

Erivan R, Villatte G, Brientini JM, Kreider D, Descamps S, Boisgard S. 7-year results of primary total hip arthroplasty with the uncemented Avenir stem. Hip Int. 2019 Jul;29(4):418-423. doi: 10.1177/1120700018810211. Epub 2018 Nov 11.
PubMed 30415580

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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All Osteoarthritis, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Non-comparative, Retrospective Post-market Surveillance Study to Obtain Clinical Outcomes Data on the Zimmer Avenir Müller Hip Stem
ClinicalTrials.gov ID: NCT04079127
Acronym / sponsor ID: 09H08
Conditions: Osteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip, Dislocated Hip, Osteonecrosis, Post-traumatic; Arthrosis
Study type: Observational
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: 9 Jan 2010 (actual)
Primary completion: 29 Jun 2019 (actual)
Study completion: 31 Aug 2019 (actual)
First posted: 6 Sep 2019 (actual)
Results: Posted 23 Jun 2020

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

Observational model: Cohort
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
Patients suffering from severe hip pain and disability	–	Device: Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.Patients in need of a total hip arthroplasty.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients suffering from severe hip pain and disability requiring a total hip arthroplasty.

Key inclusion criteria (5 listed)

Patients able to participate in a follow-up program based upon physical examination and medical history.
Patients or patient's legal representatives who have given written consent to take part in the study by signing the 'Patient Consent Form'.
18 years minimum.
Male and female.
Baseline data exist (pre-, peri- and immediate postoperative)

Key exclusion criteria (3 listed)

Patients who are unwilling or unable to comply with the follow-up program.
Known pregnancy.
Patients who are skeletally immature.

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
Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.	Device	Patients suffering from severe hip pain and disability

Primary outcome

Evaluation of Pain and Functional Performance Determined by the Harris Hip Score
Time frame: 10 years
The Harris Hip Score is a questionnaire filled by the surgeon with the patient who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction. There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).

2 secondary outcomes

Confirmation of Safety Based on Complications
Time frame: up to 10 years
Survivorship of the Implant
Time frame: 10 years

Results and safety

Results posted to the registry on 23 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Suffering From Severe Hip Pain and Disability	150	89

Primary outcome: Evaluation of Pain and Functional Performance Determined by the Harris Hip Score

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

Measure	Patients Suffering From Severe Hip Pain and Disability n = 75
Value	90.9 (11.7)

Population analysed: The HHS values are within the interval 0-100 points and the higher the score is, the better the outcome is for the individuals. The results are interpreted with the following ratings: \<70 points = poor result; 70-79 points = fair, 80-89 points = good, and 90-100 points = excellent. Number Of Unilateral Patients: 68; Number Of Bilateral Patients:7. Here, the data at 10 year post surgery of 75 patients (82 hips) were available for analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected preoperatively, intraoperatively and postoperatively (at 3-4 years, 5 years, 7 years and 10 years postoperative).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Suffering From Severe Hip Pain and Disability	17 of 141 (12.1%)	14 of 141 (9.9%)	3 of 141

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30415580Erivan R, Villatte G, Brientini JM, Kreider D, Descamps S, Boisgard S. 7-year results of primary total hip arthroplasty with the uncemented Avenir stem. Hip Int. 2019 Jul;29(4):418-423. doi: 10.1177/1120700018810211. Epub 2018 Nov 11.
Individual participant dataSharing planned: No

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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.

Paola Vivoda study director

Zimmer Biomet

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, Hip 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 5 inclusion and 3 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 14 May 2021. 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 23 Jun 2020). 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?

Evaluation of Pain and Functional Performance Determined by the Harris Hip Score (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 NCT04079127, which also lists 1 linked publication.

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 14 May 2021.