Maxera Large Cups - Canada

Terminated

• Conditions: Degenerative Joint Disease of Hip; Osteoarthritis, Hip; Congenital Dysplasia of the Hip; Post-Traumatic Osteoarthritis of Hip; Joint Diseases; Rheumatoid Arthritis of Hip; Avascular Necrosis of Hip
• Interventions: Device: Total hip arthroplasty

• Registration Number: NCT04348968
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Status Verified: 2021-03
• Study Start: 2021-03-01
• Primary Completion: 2021-03-25
• Study Completion: 2021-03-25
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient who received a Maxera Cup of large diameter	Total hip arthroplasty	Patient received a Maxera Cup with an outer diameter of 64 mm or 66 mm between Nov 2011 and Feb 2018.

Primary Outcome Measures

Name	Time	Method
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method	10 years post-surgery

Secondary Outcome Measures

Name	Time	Method
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc	10 years post-surgery
Pain and functional performance based on the Harris Hip Score	10 years post-surgery	The score is given from 0 to 100 with Excellent: 90 - 100, Good: 80 - 89, Fair: 70 - 79, and Poor: \< 70
Subject quality-of-life determined by the EQ-5D (EuroQoI) score	10 years post-surgery	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".
Safety based on eventual complications occurred including dislocations and revisions/removals	10 years post-surgery

Trial Locations

Locations (1)

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montréal, Quebec, Canada