Clinical trial NCT06518993: Observational Study to Collect Safety Data and PROMs on Primary THA
Official title: Observational Study to Collect Safety Data and Patient-reported Outcomes Measures (PROMs) on Retrospective Primary Total Hip Arthroplasty Surgeries With Trinity Cup and Meije Duo Cementless Hip Stem
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Arthritis
Osteoarthritis, Hip
Coxitis
Femoral Head Necrosis
Femoral Neck Fractures
Keywords: total hip arthroplasty
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone to a THA with Trinity cup and Meije Duo cementless hip will be invited to participate in this study. An initial review of the medical database of all Corin Trinity cup procedures performed in the selected study site will be conducted to assess the number of retrospective patients potentially available to join the study. A first contact with the patient will occur telephonically or via mail to explain the study and invite them to join.

Brief summary: This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system

Detailed description: The major goal of this study is to collect safety and patient-reported outcomes measures (PROMs) data on Trinity cup in combination with Meije Duo cementless hip stem when used in primary total hip arthroplasty (THA).

Data collected from this study will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses and/or peer-reviewed publication(s) on mid- and long-term safety and clinical performance.

Eligibility criteria: Inclusion Criteria:

* Both genders.
* Adult subjects.
* Subjects who received a primary THR with Trinity cup and Meije Duo cementless femoral stem.
* The subject is willing to comply with the required follow-up visits as per protocol.
* The subject has signed a Patient Informed Consent Form (PICF), specific to this study, and approved by the local EC.

Exclusion Criteria:

* Subjects under guardianship.
* Subjects in the opinion of the Investigator/ investigative team who will be unable to comply with study procedures (Examples: recent psychotic or mania disorders, alcohol, drug or substance abusers) and/or those unable for any medical or other reason to comply with study procedures/visits.

Primary outcomes:
measure: Evaluation of hip functional performance
timeFrame: 2 years
Secondary outcomes:
measure: Confirmation of safety of the study devices
timeFrame: 2 years
measure: Evaluation of outcome after hip arthroplasty
timeFrame: 2 years
measure: Evaluation of clinical outcomes
timeFrame: 2 years
measure: Assessment of health-related quality of life
timeFrame: 2 years
measure: Assessment of patient's satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Valenciennes
country: France
facility: CH Valenciennes
Study officials:
affiliation: CH VALENCIENNES
name: Charles BERTON, MD
role: PRINCIPAL_INVESTIGATOR
References: