Multicenter Mpact DM France
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMedacta International SA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with a disease that meets the indications for use of Medacta implants (according to the instructions for use)
Patient eligible for first-line total hip replacement
Patient between 18 and 80 years of age
Patient covered by the Social Security system or an equivalent protection plan
Disqualifiers
Patient requiring a transplant
Patient with progressive local or systemic infection
Patient with muscle loss, neuromuscular disease, or vascular impairment of the affected limb making surgery unwarranted
Patient with known medical problems that may compromise independent recovery of mobility
Trial population
The total number of patients needed for this study is 600. All patients with a condition requiring hip joint replacement will be invited to participate in the study by the investigator during consultations.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
10 years after the index surgerySecondary outcomes
1
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.
Time frame
pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery2
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.
Time frame
Intra-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgery3
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.
Time frame
pre-op, 3 months, 1 year, 3 years, 5 years and 10 years after the index surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov