Status:
TERMINATED
Maxera Large Cups - Canada
Lead Sponsor:
Zimmer Biomet
Conditions:
Degenerative Joint Disease of Hip
Osteoarthritis, Hip
Eligibility:
All Genders
18-100 years
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 Large...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 25 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04348968
Start Date
March 1 2021
End Date
March 25 2021
Last Update
April 5 2021
Active Locations (1)
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1
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, QC H1T 2M4