Mpact 3D Metal Monolit Study
ConditionTotal Hip Arthroplasty (THA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMedacta International SA
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient suffering from inflammatory arthritis
Previously operated hip
Patient requiring a transplant
Hip tumour involved
Trial population
Patients who meet the inclusion criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mpact 3D Metal Monolith
DeviceTHA with Mpact 3D Metal Monolith
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
Preoperative, 3 months, 6 months, 1 year, 2 years, 5 yearsSecondary outcomes
1
Analysis of the primary stability of the implant at 2 years
Protocol EBRA-Cup: Measurement of longitudinal/transversal migration of acetabular cup in digital serial radiographs (minimum of 4 x-rays per series). Full size AP pelvis radiographs are required. Accuracy: +/- 1mm.
Time frame
2 years2
Analysis of the wear of the polyethylene insert (HighCross) at 2 years
Martell method of linear wear measurement
Time frame
2 years3
Evaluation of the fixation and osteolysis
Radiological analysis
Time frame
Immediate postoperative, 3 months, 6 months, 1 year, 2 years, 5 years4
Evaluation of the mobility
The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure designed to assess disability in patients undergoing total hip replacement. The OHS is a short 12-item survey that can be done with pen and paper. Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.
Time frame
Preoperative, 3 months, 6 months, 1 year, 2 years, 5 yearsSponsors and contacts
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Source ClinicalTrials.gov