| NCT ID | NCT06748885 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medacta International SA |
| Condition | Total Hip Arthroplasty (THA) |
| Study Type | OBSERVATIONAL |
| Enrollment | 88 participants |
| Start Date | 2024-02-28 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 88 participants in total. It began in 2024-02-28 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Total hip arthroplasty (THA) is one of the most common operations performed in orthopaedics to improve a patient's quality of life. Surgeons are constantly seeking to improve all aspects of care related to this procedure, whether it be improving implant technology, improving instrumentation or the technique involved in performing the procedure. In recent years, a new porous titanium coating has been introduced to promote good osseointegration of uncemented cups. High friction torque and a feeling of immediate anchorage provide excellent primary stability, while high porosity ensures bone growth providing secondary stability. With higher porosity than standard coatings, a greater volume of bone can be present in the porous surface, giving a proportional increase in force at the interface. he Mpact 3D Metal Monolith cup has been designed to provide greater range of motion and improved joint stability, with a reduced risk of dislocation. It is an innovative design that improves stability and provides a favourable environment for long-term biological metal-bone fixation. The current study aims to collect clinical and radiological data to assess the function of the operated hip and the stability of the Mpact 3D Metal Monolith cup at 2 years and survival at 5 years for the treatment of patients requiring hip arthroplasty.
Eligibility Criteria
Inclusion Criteria: 1. Patient with a disease that corresponds to the indications for use of Medacta implants (according to the instructions for use) 2. Patient eligible for primary total hip arthroplasty 3. Patient aged between 18 and 75 years 4. Patient covered by the French Social Security system or an equivalent protection scheme. 5. Patient able, in the investigator's opinion, to comply with the requirements of the study. Exclusion Criteria: 1. Patient suffering from inflammatory arthritis 2. Previously operated hip 3. Patient requiring a transplant 4. Hip tumour involved 5. Patient with progressive local or systemic infection 6. Severe acetabular dysplasia 7. Patient with muscle loss, neuromuscular disease or vascular impairment of the affected limb. 4\. Patient with known medical problems that may compromise independent recovery of mobility 5. Patient with a BMI greater than 40 kg/m². 6. Patient with major cognitive impairment that prevents him/her from fully understanding the requirements of the study 7. Patient living in a geographical area where study follow-up is not possible. 8. Patient taking part in interventional research 9. Minor patient 10. Protected adult patient 11. Vulnerable person according to article L1121-6 of the Public Health Code
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06748885 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Total Hip Arthroplasty (THA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06748885 currently recruiting?
Yes, NCT06748885 is actively recruiting participants. Contact the research team at philippe.anract@aphp.fr for enrollment information.
Where is the NCT06748885 trial being conducted?
This trial is being conducted at Nantes, France, Paris, France, Paris, France.
Who is sponsoring the NCT06748885 clinical trial?
NCT06748885 is sponsored by Medacta International SA. The trial plans to enroll 88 participants.