Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

Total hip arthroplastyMedical devicePerformanceSafetyClinical benefitsHip prosthesis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Pain and functional performance based on the Harris Hip Score
10 years post-surgery
Subject quality-of-life determined by the EQ-5D (EuroQoI) score
10 years post-surgery
X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc

Study Arms (1)

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

Interventions

Total hip arthroplastyDevice

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.

Also known as: Total hip replacement

Patient who received a Maxera Cup of large diameter

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, QC H1T 2M4, Canada

MeSH Terms

Conditions

Osteoarthritis, HipHip Dislocation, CongenitalJoint Diseases

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisMusculoskeletal DiseasesRheumatic DiseasesDevelopmental Dysplasia of the HipMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Study Officials

Paola Vivoda
Zimmer Biomet
STUDY DIRECTOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

March 1, 2021

Actual (reported)

Study Stopped

Maxera Large Cups - Canada

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Patient who received a Maxera Cup of large diameter

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Patient who received a Maxera Cup of large diameter

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations