Maxera Canada: Maxera Large Cups - Canada

Sponsor

Zimmer Biomet (Industry)

Overall Status

Terminated

CT.gov ID

NCT04348968

Collaborator

(none)

Enrollment

Location

Actual Duration (Days)

25.4

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
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	Device: Total hip arthroplasty

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

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Other

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)

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Mar 25, 2021

Actual Study Completion Date :

Mar 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	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. Other Names: Total hip replacement

Arm

Intervention/Treatment

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.

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.

Other Names:

Total hip replacement

Outcome Measures

Primary Outcome Measures

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

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".
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc [10 years post-surgery]
Safety based on eventual complications occurred including dislocations and revisions/removals [10 years post-surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

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.