Clinical trial NCT06748885: Mpact 3D Metal Monolit Study
Official title: Prospective, Multicentre, Non-randomised, Open Study Evaluating the Efficacy and Fixation of the Mpact 3D Metal Monolit Cup
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Total Hip Arthroplasty (THA)
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet the inclusion criteria

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

Primary outcomes:
measure: Evaluation of the hip function
timeFrame: Preoperative, 3 months, 6 months, 1 year, 2 years, 5 years
Secondary outcomes:
measure: Analysis of the primary stability of the implant at 2 years
timeFrame: 2 years
measure: Analysis of the wear of the polyethylene insert (HighCross) at 2 years
timeFrame: 2 years
measure: Evaluation of the fixation and osteolysis
timeFrame: Immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years
measure: Evaluation of the mobility
timeFrame: Preoperative, 3 months, 6 months, 1 year, 2 years, 5 years
measure: Evaluation of the safety of the implant
timeFrame: Intraoperative, immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years
measure: Evaluation of the survival of the implant
timeFrame: 3 months, 6 months, 1 year, 2 years, 5 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: Clinique Brétéché
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
References: