Suzetrigine in Total Hip Arthroplasty
NCT07226700
Agnosia, JOURNAVX
New York, United States
View Trial DetailsNCT Number: NCT06917365
XPEO-E liner is CE marked under MDD 93/42/CEE by equivalency with CI E liner. No pertaining data on XPEO-E liner is yet available. However, clinical evaluation concludes on a reaching of performance and safety and compliance with essential requirements. This study intends to collect data on XPEO-E in order to allow a transit to MDR 2017/745 (EU).
XPEO-E liner is intended to be used with NOVAE cups and SERF femoral heads and Stems. XPEO-E liner will be used according to their CE marking. These devices are intended for hip replacements with the aim of improving quality of life and reducing pain by replacing a damaged joint.
The follow-up visits are established according to the current practice. Additional procedure will only consist on questionnaires that will be filled by the patient and/or the surgeons.
Interested in participating?
Request Info18 year and older
All sexes
Observational
CHU Dijon, Dijon, France
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Per operative period to 5 years
To assess the evolution of patient's functional capacity post-implantation using Harris Hips score (measured from 0 to 100 points, the higher the score the better the outcome)
Time frame: Per operative period to 5 years
Calculated using the Kaplan-Meier method
Time frame: Per operative period to 5 years
To assess the evolution of patient's functional capacity post-implantation using HOOS score (40-item questionnaire mesured from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms )
Time frame: Per operative period to 5 years
To assess the evolution of patient's activity post-implantation using Charnley score
Time frame: Pre operative period to 5 years
To assess patient's pain (Visual Analogic Scale measured on a scale of 0 to 10 to reflect the intensity of the pain)
Time frame: Pre operative period to 5 years
To assess patient's quality of life post-implantation (Forgotten Joint Score mesured from 0 to 100, the higher the score, the less the patient is aware of their affected joint when performing daily activities)
Time frame: Post operative period to 5 years
To assess patients' satisfaction with the operation (4-points question)
Time frame: Per operative period to 5 years
To assess the long-term safety of investigational medical devices as well as post-operative safety of the surgery
Contact information is provided by the study sponsor or research team.
Societe dEtude, de Recherche et de Fabrication
Industry
Acronym: 2024-01-XPEO-E
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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