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The notified body does not require data anymore and recruitment did not start. The study was thus terminated after approval from the investigator and the local ethical committee.
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total hip arthroplasty | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method | 10 years post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Subject quality-of-life determined by the EQ-5D (EuroQoI) score |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Paola Vivoda | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec | QC H1T 2M4 | Canada |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D006618 | Hip Dislocation, Congenital |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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|
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 |
| 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 |
| D000082602 |
| Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |