Multicenter Mpact DM France

Total Hip Arthroplasty Clinical Trial

Official title:

Prospective, Multicenter, Non-Controlled, Non-Randomized, Open-Label Study To Evaluate The Efficacy And Performance Of The Mpact® Dual Mobility Hemispheric Cup

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818891
• Other study ID #: P01.017.03
• Status: Recruiting
• Start date: April 5, 2018
• Est. completion date: April 2031

Study information

• Verified date: April 2023
• Source: Medacta International SA
• Contact: Arianna Girardi
• Phone: +41 91 696 60 60
• Email: girardi[@]medacta.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty. The primary endpoint is the 10-year life span of the prosthesis according to the Kaplan Meier curve.

Description:

The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty evaluated through the Kaplan Meier curve. The secondary objectives of the study are: - To assess the function of the operated hip - Evaluate the safety of the implant - Evaluate the stability of the prosthetic components Secondary endpoints were: - Harris Hip Score The Harris Hip Score (HHS) items include an analysis of the operated hip according to pain, function, mobility and stability and a deformity analysis. The Harris Hip Score will be used to assess the patient's subjective and objective improvement in the above criteria. - Evaluation of standard radiographs from the front and side. Periprosthetic edging and osteolysis will be evaluated using Delee and Charnley zones for the acetabular component and Gruen zones for the femoral component. - Evaluation of implant stability and fit using the ARA score. This score is used to determine whether the implant causes changes in the surrounding bone structures. If signs occur, they can be considered either as "neutral", showing a simple adaptation and not reducing the result, or as "negative" to varying degrees. The maximum ARA score is 6 points, negative points from 1 to 4 can be attributed for each of these "negative" signs. The arithmetic summation of these "risk factors" will lead to a final "score", defining the adaptation of the prosthesis to the bone sleeve at the time the images are taken, and which may naturally vary with time, either positively, if the fixation, which was precarious at the time, stabilizes (secondary osteoinduction by Hydroxyapatite of initial fibrosis zones, for example), or negatively in the presence of an evolving destabilization (there is obviously no negative score). The approach is similar for the femur and for the acetabulum. ❖ Collection of intraoperative and postoperative complications. Complications, such as infection, loosening, deep vein thrombosis (DVT), fracture, as well as other unexpected complications, will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 2031
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patient with a disease that meets the indications for use of Medacta implants (according to the instructions for use)

2. Patient eligible for first-line total hip replacement

3. Patient between 18 and 80 years of age

4. Patient covered by the Social Security system or an equivalent protection plan

5. Patient who is capable, in the opinion of the investigator, of fulfilling the requirements of the study

Exclusion Criteria:

1. Patient requiring a transplant

2. Patient with progressive local or systemic infection

3. Patient with muscle loss, neuromuscular disease, or vascular impairment of the affected limb making surgery unwarranted

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 problems that do not allow a good understanding of the study requirements

7. Patient living in a geographical area that does not allow the study follow-up

8. Patient participating in interventional research.

9. Minor patient

10. Protected adult patient

11. Vulnerable person according to article L1121-6 of the Public Health Code

12. Pregnant or nursing woman.

Related Conditions & MeSH terms

• Prosthesis Failure
• Survival, Prosthesis
• Total Hip Arthroplasty

Locations

Country	Name	City	State
France	Centre Orthopédique Médico-Chirurgical de Dracy Le Fort	Dracy-le-Fort

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.	Analysis with Kaplan Meier curve considering the revisions of the implants	10 years after the index surgery
Secondary	Evaluate the function of the operated hip	Evaluation of the Harris Hip Score with the analysis of the operated hip for pain, function, mobility and stability and a deformity analysis.; 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; Evaluation of standard radiographs from the front and side. Periprosthetic edging and osteolysis will be evaluated using Delee and Charnley zones for the acetabular component and Gruen zones for the femoral component.	pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery
Secondary	To evaluate the safety of the implant	Collecting all the adverse events through time; Collection of intraoperative and postoperative complications. Complications, such as infection, loosening, deep vein thrombosis (DVT), fracture, as well as other unexpected complications, will be evaluated.	Intra-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery
Secondary	To evaluate the stability of the prosthetic components	Evaluation of implant stability and fit using the ARA score. This score is used to determine whether the implant causes changes in the surrounding bone structures. If signs occur, they can be considered either as "neutral", showing a simple adaptation and not reducing the result, or as "negative" to varying degrees. The maximum ARA score is 6 points, negative points from 1 to 4 can be attributed for each of these "negative" signs.; The arithmetic summation of these "risk factors" will lead to a final "score", defining the adaptation of the prosthesis to the bone sleeve at the time the images are taken, and which may naturally vary with time, either positively, if the fixation, which was precarious at the time, stabilizes (secondary osteoinduction by Hydroxyapatite of initial fibrosis zones, for example), or negatively in the presence of an evolving destabilization (there is obviously no negative score). The approach is similar for the femur and for the acetabulum.	pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery