Osteoarthritis, HipNCT04731077
Avenir Complete Post-Market Clinical Follow-Up Study
A study testing Avenir Complete Femoral Stem in people with Osteoarthritis, Hip and Avascular Necrosis of Hip, run by Zimmer Biomet at 9 sites in 6 countries.
Trial summary
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Avascular Necrosis of Hip, Avascular Necrosis of the Femoral Head
- What is being tested?
- Avenir Complete Femoral Stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 27 Sep 2021to 1 Jun 2036
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 20 years old or older and skeletally mature.
- Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
- Failed previous hip surgery including
- Joint reconstruction (osteotomy)
- Arthrodesis
- Hemi-arthroplasty or total hip replacement (THR)
Show all 9Show fewer
- Acute traumatic fracture of the femoral head or neck;
- Avascular necrosis of the femoral head.
- Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
Who cannot join
- 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 Inclusion criteria
- Patient is at least 20 years old or older and skeletally mature.
- Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
- Failed previous hip surgery including
Show all 31Show fewer
- Joint reconstruction (osteotomy)
- Arthrodesis
- Hemi-arthroplasty or total hip replacement (THR)
- Acute traumatic fracture of the femoral head or neck;
- Avascular necrosis of the femoral head.
- Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study;
- 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;
- Allergy to the implanted material, especially to metal (e.g. cobalt, chromium, nickel, etc.);
- Local bone tumors and/or cysts;
- Pregnancy;
- Skeletal immaturity.
- Patients unwilling or unable to give consent, or to comply with the follow-up program;
- Patients who have any condition that would - in the judgement of the Investigator - place him/her at undue risk or
- interfere with the study;
- Any vulnerable subject:
- a prisoner
- mentally incompetent or unable to understand what participation in the study entails
- a known alcohol or drug abuser
- anticipated to be non-compliant
- Patients with plans to relocate during the study follow-up period;
- 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;
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
United States3 sites
Mississippi Sports Medicine and Orthopaedic Center PLLC
Jackson, Mississippi, 39202
Orthopedic & Fracture Clinic, PC
Portland, Oregon, 97225
Heartland Regional Medical Center d.b.a. Mosaic Life Care
Saint Joseph, Missouri, 64506
Japan2 sites
Okayama City Hospital
Okayama, 700-0962
Nissan Tamagawa Hospital
Setagaya-Ku, Tokyo, 410-0302
About this study
Official title: Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete™ Femoral Stem (Implants and Instrumentation)
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.
Read the detailed description
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete™ femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty:
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on the removal or intended removal of the "study device and determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
- Conditions
- Osteoarthritis, Hip, Avascular Necrosis of Hip, Avascular Necrosis of the Femoral Head, Post-traumatic; Arthrosis
- Being tested
- Avenir Complete Femoral Stem
- Medical subject headings
- Osteoarthritis, Hip, Femur Head Necrosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avenir Complete Femoral StemDevice
All enrolled subjects will receive the Avenir Complete Femoral Stem
| Study group | Role | What they receive |
|---|---|---|
| Avenir Complete Femoral Stem | Other | All enrolled subjects receive the study implant Receives: Device: Avenir Complete Femoral Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the study device; whether or not it is still implanted in the subject
Survival is classified as removal of the study device for any reason
Measured: 10 years
Secondary outcomes (5)
Incidence of treatment-emergent Adverse Events (safety)
Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.
Measured: 10 years
Harris Hip Score
Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction. 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: 3 years
Patient Quality of Life
This is another self-assessment by means of the EQ-5D-5L (EuroQol) score, which measures the patient's perceived quality of life.
EQ VAS: Score between 0 and 100 recorded by an individual, 100 being the highest.
EQ 5D Value: "The value attached to an EQ-5D profile according to a set of weights that reflect, on average, people's preferences about how good or bad the state is. Values are anchored at 1 (full health) and 0 (a state as bad as being dead)" https://euroqol.org/support/terminology/
Measured: 10 years
Radiographic analysis
Postoperative radiographs will be analyzed by the Investigator
Measured: 10 years
Oxford Hip Score
The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure tool designed to assess disability in patients undergoing total hip replacement.
The score is measured on a scale of 0 to 48 with 48 being the best outcome.
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 posted29 Jan 2021
- Study start27 Sep 2021
- Primary completion1 Jun 2035 (estimated)
- Study completion1 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731077
- Sponsor's protocol ID
- CMG2020-20H
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the Avenir Complete™ Femoral Stem (Implants and Instrumentation)
- ClinicalTrials.gov ID
- NCT04731077
- Acronym / sponsor ID
- CMG2020-20H
- Conditions
- Osteoarthritis, Hip, Avascular Necrosis of Hip, Avascular Necrosis of the Femoral Head, Post-traumatic; Arthrosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 1 Jun 2035 (estimated)
- Study completion
- 1 Jun 2036 (estimated)
- First posted
- 29 Jan 2021 (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 main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.
Detailed description
The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete™ femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty:
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on the removal or intended removal of the "study device and determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avenir Complete Femoral Stem | Other | Device: Avenir Complete Femoral StemAll enrolled subjects receive the study implant |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is at least 20 years old or older and skeletally mature.
- Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
- Failed previous hip surgery including
- Acute traumatic fracture of the femoral head or neck;
- Avascular necrosis of the femoral head.
Key exclusion criteria (31 listed)
- 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 Inclusion criteria
- Patient is at least 20 years old or older and skeletally mature.
- Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases;
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 |
|---|---|---|
| Avenir Complete Femoral StemAll enrolled subjects will receive the Avenir Complete Femoral Stem | Device | Avenir Complete Femoral Stem |
Primary outcome
Survival of the study device; whether or not it is still implanted in the subject
Time frame: 10 years
Survival is classified as removal of the study device for any reason
5 secondary outcomes
Incidence of treatment-emergent Adverse Events (safety)
Time frame: 10 years
Harris Hip Score
Time frame: 3 years
Patient Quality of Life
Time frame: 10 years
Radiographic analysis
Time frame: 10 years
Oxford Hip Score
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 13 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avenir Complete Femoral Stem in people with Osteoarthritis, Hip and Avascular Necrosis of Hip, run by Zimmer Biomet at 9 sites in 6 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 9 inclusion and 31 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Japan, Denmark, Netherlands, Norway and 1 more country. 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?
Survival of the study device; whether or not it is still implanted in the subject (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 13 Oct 2026.