Primary OsteoarthritisNCT03396224
Avenir® Cemented Hip Stem - PMCF
An observational study of Primary Osteoarthritis and Post-Traumatic Osteoarthritis of Hip, run by Zimmer Biomet at 3 sites in 2 countries.
Trial summary
The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip, Femoral Neck Fractures
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 Nov 2015to Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 who: * are in need of a primary total hip arthroplasty * receive the Avenir® Cemented Hip Stem and compatible femoral head and acetabular cup * meet all the inclusion criteria and none of the exclusion criteria
Who may be able to join
- Patient is 18 years of age minimum.
- Patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history.
- Patient is willing and able to cooperate in the required post-operative therapy.
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
Who cannot join
- Patient is unwilling or unable to give consent, or to comply with the follow-up program.
- Acute, chronic, local, or systemic infections.
- Severe muscular, neural, or vascular diseases that endanger the limbs involved.
- Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible.
- Total or partial absence of the muscular or ligamentous apparatus.
- Any concomitant diseases that can jeopardize the functioning and the success of the implant.
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- Allergy to the implanted material, especially to metal (e.g., stainless steel).
- Local bone tumors and/or cysts.
- Pregnancy
- Skeletal immaturity
- Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, a known drug abuser or alcoholic or anyone who cannot understand what is required of them.
- Patients with plans to relocate during the study follow-up period.
- For patients biologically younger than 60 years with joint disease, a different reconstruction operation (e.g., osteotomy) or arthrodesis may be indicated.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Hôpital Gabriel Montpied - Service de chirurgie Orthopédique
Clermont-Ferrand, Auvergne-Rhône-Alpes, 63003
Hopital Lapeyronie - Service Orthopédie
Montpellier, Occitanie, 34295
Belgium1 site
Cliniques Universitaires St-Luc UCL
Woluwe-Saint-Lambert, Brussels Capital, 1200
About this study
Official title: Prospective Post Market Clinical Follow-up Study of the Avenir® Cemented Hip Stem
The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.
Read the detailed description
This is a multicenter, prospective, non-controlled post-market clinical follow-up study to fulfill the post market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2.
The objectives of this study are to confirm the safety and performance of the Avenir Cemented Hip Stem when used in primary total hip arthroplasty at 6 weeks to 6 months, 1, 2, 3, 5, 7 and 10 years post-operatively.
The Avenir Cemented Hip Stem is a straight double-tapered stem offering 9 standard and 9 lateralized versions, the same as the uncemented version, the Avenir-Mueller Stem.
Safety will be evaluated by monitoring the frequency and incidence of adverse events and through radiographic review.
Performance will be based on the implant survival, overall pain and functional performances, subject quality-of-life and radiographic parameters of study subjects who received the Avenir® Cemented Hip stem.
Implant survival will be based on removal or intended removal of the device.
A total of 130 patients will be enrolled into the study at up to 4 sites.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip, Femoral Neck Fractures, Femoral Head Necrosis, Sequelae From Previous Hip Surgery, Osteotomies
- Keywords
- Total hip arthroplasty, Hip implant
- Medical subject headings
- Femoral Neck Fractures, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received the Avenir® Cemented Hip Stem | Patients suffering from severe hip pain and disability requiring total hip arthroplasty and who meet the inclusion/exclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Measured: 10 years
Secondary outcomes (4)
The results of the hip surgery will be 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
The patient's quality-of-life will be determined by the EQ-5D score
EQ-5D is a standardized instrument for measuring health status. It is made up for two components.
The description part: health status is measured in five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself. Usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have. In anxiety/depression dimension, it asks how anxious or depressed they are.
Visual analogue scale: The patient marks his health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. The bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".
Measured: 10 years
Abnormalities determined on X-rays in the bone region surrounding the implant will be reported
Measured: 10 years
Number of patient with adverse events related to the implant will be reported
Adverse events include: dislocations of the hip, revisions and removals of the implants
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start18 Nov 2015
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Achakri, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396224
- Sponsor's protocol ID
- CME2013-03H
- Status last verified
- Nov 2025
- First submitted
- 11 Dec 2017
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post Market Clinical Follow-up Study of the Avenir® Cemented Hip Stem
- ClinicalTrials.gov ID
- NCT03396224
- Acronym / sponsor ID
- CME2013-03H
- Conditions
- Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip, Femoral Neck Fractures, Femoral Head Necrosis, Sequelae From Previous Hip Surgery, Osteotomies
- Keywords
- Total hip arthroplasty, Hip implant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 10 Jan 2018 (actual)
- 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.
The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.
Detailed description
This is a multicenter, prospective, non-controlled post-market clinical follow-up study to fulfill the post market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2.
The objectives of this study are to confirm the safety and performance of the Avenir Cemented Hip Stem when used in primary total hip arthroplasty at 6 weeks to 6 months, 1, 2, 3, 5, 7 and 10 years post-operatively.
The Avenir Cemented Hip Stem is a straight double-tapered stem offering 9 standard and 9 lateralized versions, the same as the uncemented version, the Avenir-Mueller Stem.
Safety will be evaluated by monitoring the frequency and incidence of adverse events and through radiographic review.
Performance will be based on the implant survival, overall pain and functional performances, subject quality-of-life and radiographic parameters of study subjects who received the Avenir® Cemented Hip stem.
Implant survival will be based on removal or intended removal of the device.
A total of 130 patients will be enrolled into the study at up to 4 sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received the Avenir® Cemented Hip Stem | – | –Patients suffering from severe hip pain and disability requiring total hip arthroplasty and who meet the inclusion/exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who: * are in need of a primary total hip arthroplasty * receive the Avenir® Cemented Hip Stem and compatible femoral head and acetabular cup * meet all the inclusion criteria and none of the exclusion criteria
Key inclusion criteria (4 listed)
- Patient is 18 years of age minimum.
- Patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history.
- Patient is willing and able to cooperate in the required post-operative therapy.
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
Key exclusion criteria (13 listed)
- Patient is unwilling or unable to give consent, or to comply with the follow-up program.
- Acute, chronic, local, or systemic infections.
- Severe muscular, neural, or vascular diseases that endanger the limbs involved.
- Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible.
- Total or partial absence of the muscular or ligamentous apparatus.
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
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Time frame: 10 years
4 secondary outcomes
The results of the hip surgery will be determined by the Harris Hip Score
Time frame: 10 years
The patient's quality-of-life will be determined by the EQ-5D score
Time frame: 10 years
Abnormalities determined on X-rays in the bone region surrounding the implant will be reported
Time frame: 10 years
Number of patient with adverse events related to the implant will be reported
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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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.
Hassan Achakri study director
Zimmer Biomet
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Osteoarthritis and Post-Traumatic Osteoarthritis of Hip, run by Zimmer Biomet at 3 sites in 2 countries.
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 13 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: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. 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 France, Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.