Primary OsteoarthritisNCT03357445
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
A study testing Avantage Reload cup in people with Primary Osteoarthritis and Post-Traumatic Arthritis, run by Zimmer Biomet at 4 sites in 2 countries.
Trial summary
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Osteoarthritis, Post-Traumatic Arthritis, Inflammatory Joint Disease
- What is being tested?
- Avantage Reload cup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Oct 2011to 27 Apr 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically
- Primary osteoarthritis
- Post-Traumatic arthritis
- Inflammatory joint disease (e.g. Rheumatoid arthritis)
- Femoral neck fracture
- Femoral head necrosis
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- Sequelae from previous hip surgery, osteotomies, etc.
- Congenital hip dysplasia
- Additional inclusion criteria include:
- Male or female
- 18 years of age or older
- Subjects willing to return for follow-up evaluations
- Subjects who read, understand study information and give written consent (specific local regulatory requirements)
Who cannot join
- Exclusion criteria should be in accordance with Contraindications for the AVANTAGE®
- RELOAD:
- Absolute contraindications include:
- Infection
- Sepsis
- Severe muscular, neurological or vascular deficiencies of the extremity involved
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- Bone destruction or poor bone quality
- Additional contraindications include:
- Subjects unable to co-operate with and complete the study
- Dementia and inability to understand and follow instructions
- Neurological conditions affecting movement
- Patient over 18 under law supervision
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
CHU Cote de Nacre
Caen
Hôpital Renée Sabran
Giens
CHU Lapeyronie
Montpellier
About this study
Official title: Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
Read the detailed description
The study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the AVANTAGE RELOAD cup. Secondary objective is to evaluate the polyethylene wear between E1 and ARCOM.
500 patients was the enrollment goal with 2 subgroups.
- Subgroup 1: prospective and non-controlled to satisfy ODEP (Orthopedic Device Evaluation Panel) requirements;
- Subgroup 2: randomized and controlled to compare the polyethylene wear between the Arcom and the E1 liners.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Arthritis, Inflammatory Joint Disease, Femoral Neck Fracture, Femoral Head Necrosis, Sequelae From Previous Hip Surgery
- Being tested
- Avantage Reload cup
- 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.
Avantage Reload cupOther
Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Subgroup 1 | Other | Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD Receives: Other: Avantage Reload cup |
| Subgroup 2 | Other | Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner Receives: Other: Avantage Reload cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Implant survivorship
Measured: 10 years post-surgery
Secondary outcomes (4)
Harris hip scores
To measure clinical efficacy
Measured: 10 years post-surgery
EQ-5D
To measure clinical efficacy
Measured: 10 years post-surgery
Radiographic Evaluation
Abnormalities determined on X-rays in the bone region surrounding the implant will be reported (radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc)
Measured: 10 years post-surgery
Complications
Eventual complications occurred including dislocations and revisions/removals
Measured: 10 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start14 Oct 2011
- Primary completion27 Apr 2027 (estimated)
- Study completion27 Apr 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 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
- NCT03357445
- Sponsor's protocol ID
- BMETEU.CR.EU49
- Status last verified
- Nov 2024
- First submitted
- 23 Nov 2017
- Last updated
- 14 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT03357445
- Acronym / sponsor ID
- BMETEU.CR.EU49
- Conditions
- Primary Osteoarthritis, Post-Traumatic Arthritis, Inflammatory Joint Disease, Femoral Neck Fracture, Femoral Head Necrosis, Sequelae From Previous Hip Surgery
- Keywords
- Total hip Arthroplasty, Hip implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2011 (actual)
- Primary completion
- 27 Apr 2027 (estimated)
- Study completion
- 27 Apr 2027 (estimated)
- First posted
- 29 Nov 2017 (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.
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
Detailed description
The study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the AVANTAGE RELOAD cup. Secondary objective is to evaluate the polyethylene wear between E1 and ARCOM.
500 patients was the enrollment goal with 2 subgroups.
- Subgroup 1: prospective and non-controlled to satisfy ODEP (Orthopedic Device Evaluation Panel) requirements;
- Subgroup 2: randomized and controlled to compare the polyethylene wear between the Arcom and the E1 liners.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subgroup 1 | Other | Other: Avantage Reload cupProspective non Controlled to Document long term performance of AVANTAGE® RELOAD |
| Subgroup 2 | Other | Other: Avantage Reload cupRandomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically
- Male or female
- 18 years of age or older
- Subjects willing to return for follow-up evaluations
- Subjects who read, understand study information and give written consent (specific local regulatory requirements)
Key exclusion criteria (12 listed)
- Exclusion criteria should be in accordance with Contraindications for the AVANTAGE®
- Infection
- Sepsis
- Severe muscular, neurological or vascular deficiencies of the extremity involved
- Bone destruction or poor bone quality
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 |
|---|---|---|
| Avantage Reload cupPatients receiving the Avantage Reload acetabular cup in total hip arthroplasty | Other | Subgroup 1, Subgroup 2 |
Primary outcome
Survivorship
Time frame: 10 years post-surgery
Implant survivorship
4 secondary outcomes
Harris hip scores
Time frame: 10 years post-surgery
EQ-5D
Time frame: 10 years post-surgery
Radiographic Evaluation
Time frame: 10 years post-surgery
Complications
Time frame: 10 years post-surgery
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 14 Nov 2024.
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avantage Reload cup in people with Primary Osteoarthritis and Post-Traumatic Arthritis, run by Zimmer Biomet at 4 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 13 inclusion and 12 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 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Slovenia. 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?
Survivorship (time frame: 10 years post-surgery). 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 14 Nov 2024.