Clinical trial NCT05848024: EBRA Study AMISTEM-C FR
Official title: Prospective, Single-Center, Non-Controlled, Non-Randomized, Open Study Evaluating the Performance and Stability of Amistem® C
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Total Hip Arthroplasty
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2023-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement and who will receive an AMIStem® C cemented femoral stem.

Patients will be able to participate in other non-interventional research during the study.

Brief summary: Primary objective: Evaluate femoral stem migration Secondary objective: Evaluate the performance of AMIStem H Proximal Coating at 10 years after surgery; assessment of functional recovery; radiological evaluation; reporting of complications

Scores collected:

HHS, OHS, PMA, UCLA

Detailed description: The main objective of the study was to evaluate the migration and performance of the AMIStem® C femoral stem at 10 years follow-up.

The primary endpoint is the measurement of femoral component migration by EBRA-FCA (The Ein Bild Roentgen Analyse-femoral component analysis, Innsbruck, Austria)

The secondary objectives of the study are:

Evaluate the performance of the AMIStem® C stem Evaluate the function of the operated hip To evaluate the quality of life To evaluate the safety of the AMIStem® C femoral stem Evaluate the postoperative stability and fixation of the hip prosthesis

Eligibility criteria: The inclusion criteria are:

1. Patient with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head...) requiring the placement of a total hip prosthesis.
2. Patient who will receive an AMIStem® C cemented femoral stem.
3. Patient willing to comply with the study requirements
4. Patient who has signed the information letter agreeing to the processing of their data in the clinical evaluation
5. Patient affiliated to a social security system
6. Patients aged 18 to 85 years

The criteria for non-inclusion are:

1. Participation in biomedical research
2. Minor patients
3. Protected adult patients
4. Vulnerable persons according to article L1121-6 of the Public Health Code
5. Pregnant or breastfeeding women
6. Patients unable to formulate their non-opposition
7. Patient refusing collection of personal data

Primary outcomes:
measure: Assess the femoral stem migration
timeFrame: 2 years
Secondary outcomes:
measure: Assess the AMIStem C performance at 10 years
timeFrame: 10 years
measure: Assess the functionality of the operated hip
timeFrame: pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
measure: Assess the Quality of Life of patients
timeFrame: pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
measure: Assess the security of AMIStem C and collect complications
timeFrame: pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
measure: Assess the postoperative stability and fixation of AMIStem C
timeFrame: pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
measure: Radiological analysis
timeFrame: pre-op, 7 days, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
Other outcomes:
Locations:
city: Arras
country: France
facility: Hôpital privé Arras Les Bonnettes
Study officials:
affiliation: Hôpital privé Arras Les Bonnettes 2 rue du docteur Forgeois 62012 Arras
name: Donatien Bocquet
role: PRINCIPAL_INVESTIGATOR
References: