An interventional study of Avantage Reload cup in Primary Osteoarthritis, Post-Traumatic Arthritis and Inflammatory Joint Disease, sponsored by Zimmer Biomet. Active, not recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Zimmer Biomet · Not applicable, Interventional, and Other
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
The study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the AVANTAGE RELOAD cup. Secondary objective is to evaluate the polyethylene wear between E1 and ARCOM.
500 patients was the enrollment goal with 2 subgroups.
207 studies on the registry are indexed under Femoral Neck Fractures; 40 are open to participants now.
This study's enrollment of 500 is above the median of 100 across 142 interventional studies indexed under Femoral Neck Fractures.
Browse Femoral Neck Fractures studies →Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically
Additional inclusion criteria include:
Exclusion Criteria:
RELOAD:
Absolute contraindications include:
Additional contraindications include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD
Other: Avantage Reload cup
Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner
Other: Avantage Reload cup
Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty
Survivorship
Implant survivorship
Time frame: 10 years post-surgery
Harris hip scores
To measure clinical efficacy
Time frame: 10 years post-surgery
EQ-5D
To measure clinical efficacy
Time frame: 10 years post-surgery
Radiographic Evaluation
Abnormalities determined on X-rays in the bone region surrounding the implant will be reported (radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc)
Time frame: 10 years post-surgery
Complications
Eventual complications occurred including dislocations and revisions/removals
Time frame: 10 years post-surgery
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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