Mpact 3D Metal Monolit Study

NCT06748885 | Recruiting

• 1 other identifier: P01.028.01
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 3

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.

Conditions

Total Hip Arthroplasty (THA)

Outcome Measures

Primary Outcomes (1)

• Evaluation of the hip function

  The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The original version was published 1969\[1\]. The HHS is an outcome measure administered by a qualified health care professional, such as a physician or a physical therapist. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

  Preoperative, 3 months, 6 months, 1 year, 2 years, 5 years

Secondary Outcomes (6)

• Analysis of the primary stability of the implant at 2 years

  2 years

• Analysis of the wear of the polyethylene insert (HighCross) at 2 years

  2 years

• Evaluation of the fixation and osteolysis

  Immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years

• Evaluation of the mobility

  Preoperative, 3 months, 6 months, 1 year, 2 years, 5 years

• Evaluation of the safety of the implant

  Intraoperative, immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years

Interventions

Mpact 3D Metal Monolith DEVICE

THA with Mpact 3D Metal Monolith

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who meet the inclusion criteria

You may qualify if:

• Patient with a disease that corresponds to the indications for use of Medacta implants (according to the instructions for use)
• Patient eligible for primary total hip arthroplasty
• Patient aged between 18 and 75 years
• Patient covered by the French Social Security system or an equivalent protection scheme.
• Patient able, in the investigator's opinion, to comply with the requirements of the study.

You may not qualify if:

• Patient suffering from inflammatory arthritis
• Previously operated hip
• Patient requiring a transplant
• Hip tumour involved
• Patient with progressive local or systemic infection
• Severe acetabular dysplasia
• Patient with muscle loss, neuromuscular disease or vascular impairment of the affected limb.
• \. 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

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (3)

Clinique Brétéché

Nantes, 44000, France

NOT YET RECRUITING

Hôpital Lariboisière

Paris, 75010, France

NOT YET RECRUITING

Hôpital Cochin

Paris, 75014, France

RECRUITING

Central Study Contacts

Philippe Anract

CONTACT

01 58 41 30 38; philippe.anract@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 27, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

FR (3)