Degenerative Joint Disease of HipMaxera CanadaNCT04348968
Maxera Large Cups - Canada
An observational study of Degenerative Joint Disease of Hip and Osteoarthritis, Hip, run by Zimmer Biomet at 1 site in Canada.
Trial summary
This study is monocentric, retrospective and prospective, non-controlled, consecutive series Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Largest Zimmer® Maxera™ Cup (Implants and Instrumentation) Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Degenerative Joint Disease of Hip, Osteoarthritis, Hip, Avascular Necrosis of Hip
- What is being tested?
- Total hip arthroplasty
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to 25 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Adult, Older adult
Study population: The investigator provided a list of 32 patients operated consecutively between Nov 2011 and Feb 2018. These patients received the Maxera Cup of outer diameter 64 or 66 mm. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant. The investigator will contact these patients to propose study enrollment until he can ensure 20 consecutive THA procedures. He will get their informed consent and retrospectively collect the preop, surgery, immed postop, and 1 year data These 20 patients will be followed-up in the frame of the standard clinicla routine and clinical data will be prospectively collected by the investigator at the 5, 7 and 10-year follow-up visits
Who may be able to join
- Patient received a Maxera Cup with an outer diameter of 64 mm or 66 mm.
- The Zimmer Maxera Cup is indicated for non-cemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of non-inflammatory degenerative joint disease (NIDJD) including but not limited to osteoarthritis, avascular necrosis, post-traumatic arthritis, congenital hip dysplasia, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate.
Who cannot join
- Active, old, or remote infection of the hip.
- Osteoradionecrosis.
- Local bone tumors and/or cysts.
- Patients with poor bone quality, where there is inadequate bone to support the implant(s).
- Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation.
- Allergy to the implanted material.
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- Patient's physical conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, e.g. previous surgery, insufficient quality or quantity of bone resulting from conditions such as cancer or congenital dislocation, metabolic bone disease of the upper femur or pelvis, femoral osteotomy revision, girdle stone revision, osteoporosis, osteomyelitis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures, joint neuropathy) or other conditions that may lead to inadequate skeletal fixation
- Do not use ceramic femoral heads which are not BIOLOX delta or BIOLOX OPTION with Maxera components.
- Use of this device when a less invasive procedure would be sufficient.
- Skeletal immaturity.
- Any nerve or muscle disease that may have a negative effect on gait or weight bearing
- Loss of abductor musculature in the affected limb.
- Poor skin coverage around the hip joint.
- Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective and Prospective Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Maxera™ Cup (Implants and Instrumentation)
This study is monocentric, retrospective and prospective, non-controlled, consecutive series Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Largest Zimmer® Maxera™ Cup (Implants and Instrumentation)
Read the detailed description
The Zimmer Maxera Cup is a monoblock construct that consists of a preassembled shell and liner. The ceramic liner articulates with a ceramic femoral head for a ceramic-on-ceramic large diameter head articulation.
The BIOLOX® delta ceramic liner (insert) is preassembled to lock into the tapered shell's cavity and articulate with BIOLOX OPTION ceramic femoral heads, sizes 32, 36, 40, 44, and 48 mm and standard BIOLOX delta ceramic femoral head sizes 32, 36, and 40 mm.
This is a single center post-market clinical evaluation. A consecutive series of 32 patients treated with a Maxera Cup (outer diameter 64 mm or 66 mm) between Nov 2011 and Feb 2018 will be identified and invited to participate in the study.
- Conditions
- Degenerative Joint Disease of Hip, Osteoarthritis, Hip, Avascular Necrosis of Hip, Post-Traumatic Osteoarthritis of Hip, Congenital Dysplasia of the Hip, Joint Diseases
- Being tested
- Total hip arthroplasty
- Keywords
- Total hip arthroplasty, Medical device, Performance, Safety, Clinical benefits, Hip prosthesis
- Medical subject headings
- Osteoarthritis, Hip, Hip Dislocation, Congenital, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip arthroplastyDevice
Also called Total hip replacement
The THA surgical procedure involves replacing the head of the femur and acetabulum or socket with an artificial prosthesis. This system is composed of a femoral stem that is inserted into the femoral canal, a ball that attaches to the femoral stem, and an acetabular component or shell that replaces the acetabulum.
In this study, the acetabular component is the Zimmer Maxera Cup, which is a monoblock construct consisting of a pre-assembled shell and liner. The ceramic liner articulates with a ceramic femoral head for a ceramic-on-ceramic large diameter head articulation. The Maxera Cup is intended for single use only and is designed for reconstruction of the hip joint for conditions described in the inclusion and exclusion section of this protocol.
| Study group | Role | What they receive |
|---|---|---|
| Patient who received a Maxera Cup of large diameter | Patient received a Maxera Cup with an outer diameter of 64 mm or 66 mm between Nov 2011 and Feb 2018. Receives: Device: Total hip arthroplasty |
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 post-surgery
Secondary outcomes (4)
Pain and functional performance based on the Harris Hip Score
The score is given from 0 to 100 with Excellent: 90 - 100, Good: 80 - 89, Fair: 70 - 79, and Poor: < 70
Measured: 10 years post-surgery
Subject quality-of-life determined by the EQ-5D (EuroQoI) score
The lowest score (0) corresponds to "the worst health the patient can imagine", and the highest rate (100) corresponds to "the best health he can imagine".
Measured: 10 years post-surgery
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
Measured: 10 years post-surgery
Safety based on 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 posted16 Apr 2020
- Study start1 Mar 2021
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Why it stopped: The notified body does not require data anymore and recruitment did not start. The study was thus terminated after approval from the investigator and the local ethical committee.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint Disease of 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paola Vivoda, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348968
- Sponsor's protocol ID
- MDRG2017-89MS-15H
- Acronym
- Maxera Canada
- Status last verified
- Mar 2021
- First submitted
- 14 Apr 2020
- Last updated
- 5 Apr 2021
- 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 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Maxera™ Cup (Implants and Instrumentation)
- ClinicalTrials.gov ID
- NCT04348968
- Acronym / sponsor ID
- Maxera Canada / MDRG2017-89MS-15H
- Conditions
- Degenerative Joint Disease of Hip, Osteoarthritis, Hip, Avascular Necrosis of Hip, Post-Traumatic Osteoarthritis of Hip, Congenital Dysplasia of the Hip, Joint Diseases
- Keywords
- Total hip arthroplasty, Medical device, Performance, Safety, Clinical benefits, Hip prosthesis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The notified body does not require data anymore and recruitment did not start. The study was thus terminated after approval from the investigator and the local ethical committee.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 16 Apr 2020 (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 study is monocentric, retrospective and prospective, non-controlled, consecutive series Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Largest Zimmer® Maxera™ Cup (Implants and Instrumentation)
Detailed description
The Zimmer Maxera Cup is a monoblock construct that consists of a preassembled shell and liner. The ceramic liner articulates with a ceramic femoral head for a ceramic-on-ceramic large diameter head articulation.
The BIOLOX® delta ceramic liner (insert) is preassembled to lock into the tapered shell's cavity and articulate with BIOLOX OPTION ceramic femoral heads, sizes 32, 36, 40, 44, and 48 mm and standard BIOLOX delta ceramic femoral head sizes 32, 36, and 40 mm.
This is a single center post-market clinical evaluation. A consecutive series of 32 patients treated with a Maxera Cup (outer diameter 64 mm or 66 mm) between Nov 2011 and Feb 2018 will be identified and invited to participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient who received a Maxera Cup of large diameter | – | Device: Total hip arthroplastyPatient received a Maxera Cup with an outer diameter of 64 mm or 66 mm between Nov 2011 and Feb 2018. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The investigator provided a list of 32 patients operated consecutively between Nov 2011 and Feb 2018. These patients received the Maxera Cup of outer diameter 64 or 66 mm. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant. The investigator will contact these patients to propose study enrollment until he can ensure 20 consecutive THA procedures. He will get their informed consent and retrospectively collect the preop, surgery, immed postop, and 1 year data These 20 patients will be followed-up in the frame of the standard clinicla routine and clinical data will be prospectively collected by the investigator at the 5, 7 and 10-year follow-up visits
Key inclusion criteria (2 listed)
- Patient received a Maxera Cup with an outer diameter of 64 mm or 66 mm.
- The Zimmer Maxera Cup is indicated for non-cemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of non-inflammatory degenerative joint disease (NIDJD) including but not limited to osteoarthritis, avascular necrosis, post-traumatic arthritis, congenital hip dysplasia, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate.
Key exclusion criteria (14 listed)
- Active, old, or remote infection of the hip.
- Osteoradionecrosis.
- Local bone tumors and/or cysts.
- Patients with poor bone quality, where there is inadequate bone to support the implant(s).
- Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation.
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 |
|---|---|---|
| Total hip arthroplastyAlso: Total hip replacementThe THA surgical procedure involves replacing the head of the femur and acetabulum or socket with an artificial prosthesis. This system is composed of a femoral stem that is inserted into the femoral canal, a ball that attaches to the femoral stem, and an acetabular component or shell that replaces the acetabulum. In this study, the acetabular component is the Zimmer Maxera Cup, which is a monoblock construct consisting of a pre-assembled shell and liner. The ceramic liner articulates with a ceramic femoral head for a ceramic-on-ceramic large diameter head articulation. The Maxera Cup is intended for single use only and is designed for reconstruction of the hip joint for conditions described in the inclusion and exclusion section of this protocol. | Device | Patient who received a Maxera Cup of large diameter |
Primary outcome
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
Time frame: 10 years post-surgery
4 secondary outcomes
Pain and functional performance based on the Harris Hip Score
Time frame: 10 years post-surgery
Subject quality-of-life determined by the EQ-5D (EuroQoI) score
Time frame: 10 years post-surgery
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
Time frame: 10 years post-surgery
Safety based on eventual complications occurred including dislocations and revisions/removals
Time frame: 10 years post-surgery
Results and safety
The study was stopped early (reason given: The notified body does not require data anymore and recruitment did not start. The study was thus terminated after approval from the investigator and the local ethical committee.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Joint Disease of Hip and Osteoarthritis, Hip, run by Zimmer Biomet at 1 site in Canada.
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 2 inclusion and 14 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: stopped early, as of the sponsor's last update on 5 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was stopped early (reason given: The notified body does not require data anymore and recruitment did not start. The study was thus terminated after approval from the investigator and the local ethical committee.). Results are not available in the source record.
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 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 5 Apr 2021.