Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay

Sponsor

Medacta International SA (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06012656

Collaborator

(none)

100

Enrollment

Location

144

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a post-marketing surveillance on MiniMAX Stem

Condition or Disease	Intervention/Treatment	Phase
Primary Osteoarthritis Secondary Osteoarthritis Traumatic Arthritis Rheumatoid Arthritis Congenital Hip Dysplasia Avascular Necrosis Fracture; Femur, Head	Device: MiniMAX

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective, Multricentre, Non Controlled, Non-randomized, Open Study for the Evaluation of the Cementless Anatomic Femoral Stem MiniMAX

Actual Study Start Date :

Jan 2, 2019

Anticipated Primary Completion Date :

Jan 2, 2029

Anticipated Study Completion Date :

Jan 2, 2031

Outcome Measures

Primary Outcome Measures

Survival Rate [10 years]
Kaplan Meier method

Secondary Outcome Measures

Functional evaluation [Pre-op, 3 months, 1, 3, 5, 10 years]
Harris Hip Score (HHS): the HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. 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 patient satisfaction [Pre-op, 3 months, 1, 3, 5, 10 years]
HOOS (hip disability and osteoarthritis outcome score) questionnaire: HOOS is a questionnaire intended to be used to assess patient's opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during a therapeutic process.The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
Evaluation of the stem fixation [Pre-op, 3 months, 1, 3, 5, 10 years]
Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.
Evaluation of the general and thigh pain [Pre-op, 3 months, 1, 3, 5, 10 years]
Echelle Visuelle Analogique (EVA) and pain location. Interpretation of the EVA scale: no pain 0, low pain 1-3, moderate pain 4-6, severe pain 7-9, extreme pain 10.
Incidence of adverse events [Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years]
Intraoperative and postoperative complications
Evaluation of the stability of the stem [Pre-op, 3 months, 1, 3, 5, 10 years]
Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient with a clinical condition requiring THA
Patient receiving a MiniMAX® stem
Patient aged more than 18 years
Patient having a Social Insurance or a similar protection regime
Patient eligible for an AMIS procedure
Patient able to follow the study requirements
Patients who are willing to give informed written consent

Exclusion Criteria:

Patient with local or systemic infection
Participation to biomedical research
Patient whose BMI exceeds 40
Patient with less than 18 years
Protected adults
Vulnerable person according to article L1121-6 of the Code de la Santè Publique.
Pregnant or lactating woman
Patient unable to express his/ her opinion about the participation to the study