MFinity BE Pre-market Trial
ConditionTotal Hip Arthroplasty (THA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedacta International SA
About this trial
The primary objective of this trial is to determine the implant survival at 1 year of follow up in a population of patients undergoing primary Total Hip Replacement with MFinity Collared Femoral stem and to test its non-inferiority compared to other cementless implant (as reported by the EPRD registry).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective primary total hip arthroplasty for primary osteoarthritis, who are suitable for implantation of a cementless femoral stem according to the MFinity femoral stem Instructions for Use
Skeletally mature adult aged 18 years and older at the time of enrollment.
Ability to give informed consent.
Patient is informed of the conditions of the study and is willing to participate for the length of the prescribed follow-up period.
Disqualifiers
Not meeting the inclusion criteria.
Active infection within the affected hip joint.
Previous total hip replacement or hip fusion of the affected hip joint.
Neuromuscular or neurosensory deficiency limiting the ability to evaluate the safety and effectiveness of the device.
Trial design
Design model
Single group
Treatments tested in this trial
Mfinity collared stem
DeviceThe MFinity Femoral Stem is intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The devices are made of Ti6Al7Nb and coated in the proximal end of the shaft with TiGrowth-C titanium. The thickness of the Ti coating is 700μm while the thickness of the HA coating is 80μm.
Treatment groups
95 Participants
are divided into 1 treatment groupGroup A: Single-ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Implant survival rate (%) assessed by Kaplan-Meier analysis at 1 year
The survival rate according to a Kaplan Meier curve. The Kaplan-Meier method calculates the survival of the prosthesis by measuring the fraction of living subjects during a period after the procedure. Each time an expected event occurs (revision of the prosthesis, patients lost to follow-up, death, etc.), the probability of implant survival changes. This information is used to estimate the performance of the prosthesis. During the study, the number of stem revisions and the number of patients who died or were lost to follow-up will be collected to calculate the probability of survival. The time of occurrence will be recorded for each event.
Time frame
1 yearSecondary outcomes
1
Implant survival rate (%) assessed by Kaplan-Meier analysis at 2 years
The survival rate according to a Kaplan Meier curve. The Kaplan-Meier method calculates the survival of the prosthesis by measuring the fraction of living subjects during a period after the procedure. Each time an expected event occurs (revision of the prosthesis, patients lost to follow-up, death, etc.), the probability of implant survival changes. This information is used to estimate the performance of the prosthesis. During the study, the number of stem revisions and the number of patients who died or were lost to follow-up will be collected to calculate the probability of survival. The time of occurrence will be recorded for each event.
Time frame
2 years2
Harris Hip Score
Evaluation of the Harris Hip Score The Harris Hip Score (HHS) items include an analysis of the operated hip according to pain, function, mobility, stability and deformity analysis. The Harris Hip Score will be used to assess the patient's subjective and objective improvement in the above criteria. The usefulness of this score has been studied to estimate the clinical results after THR, it is a reference score in the field of orthopedics. The Harris hip score is scored from 0 (worst functional outcome and maximum pain) to 100 points (best functional outcome and least pain).
Time frame
Pre-op, 6 weeks, 3 months, 1 and 2 years3
Forgotten Joint Score-12 (FJS-12)
Evaluation of the Forgotten Joint Score TheForgotten Joint Score-12 (FJS-12) is a patient-reported outcome measure assessing patients' awareness of the artificial joint during activities of daily living. The questionnaire consists of 12 items, each scored on a 5-point Likert scale (0 = never aware, 4 = mostly aware). Raw scores are summed and linearly transformed to a 0-100 scale, with higher scores indicating less joint awareness and therefore a better outcome.
Time frame
Pre-op, 6 weeks, 3 months, 1 and 2 years4
Incidence of device deficiencies
Number of device deficiencies reported during the study. Device deficiencies will be documented by the investigator using the dedicated device deficiency reporting form.
Time frame
From surgery to 2 years post-operativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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