Clinical trial NCT04348968: Maxera Large Cups - Canada
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Joint Disease of Hip
Osteoarthritis, Hip
Avascular Necrosis of Hip
Post-Traumatic Osteoarthritis of Hip
Congenital Dysplasia of the Hip
Joint Diseases
Rheumatoid Arthritis of Hip
Keywords: Total hip arthroplasty
Medical device
Performance
Safety
Clinical benefits
Hip prosthesis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2020-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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)

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
timeFrame: 10 years post-surgery
Secondary outcomes:
measure: Pain and functional performance based on the Harris Hip Score
timeFrame: 10 years post-surgery
measure: Subject quality-of-life determined by the EQ-5D (EuroQoI) score
timeFrame: 10 years post-surgery
measure: X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc
timeFrame: 10 years post-surgery
measure: Safety based on eventual complications occurred including dislocations and revisions/removals
timeFrame: 10 years post-surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
affiliation: Zimmer Biomet
name: Paola Vivoda
role: STUDY_DIRECTOR
References: