Maxera Large Cups - Canada

Osteoarthritis, Hip Clinical Trial

— Maxera 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04348968
• Other study ID #: MDRG2017-89MS-15H
• Status: Terminated
• Start date: March 1, 2021
• Est. completion date: March 25, 2021

Study information

• Verified date: March 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 25, 2021
• Est. primary completion date: March 25, 2021
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Congenital Dysplasia of the Hip
• Degenerative Joint Disease of Hip
• Hip Dislocation, Congenital
• Joint Diseases
• Necrosis
• Osteoarthritis
• Osteoarthritis, Hip
• Post-Traumatic Osteoarthritis of Hip
• Rheumatoid Arthritis of Hip

Intervention

Device:
• Total hip arthroplasty
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.

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method		10 years post-surgery
Secondary	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	10 years post-surgery
Secondary	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".	10 years post-surgery
Secondary	X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc		10 years post-surgery
Secondary	Safety based on eventual complications occurred including dislocations and revisions/removals		10 years post-surgery