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

N/AActive Not RecruitingNCT06012656

Medacta International SA100 enrolled

Overview

This is a post-marketing surveillance on MiniMAX Stem

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Primary Osteoarthritis Secondary Osteoarthritis Traumatic Arthritis Rheumatoid Arthritis Congenital Hip Dysplasia Avascular Necrosis Fracture; Femur, Head

Interventions

MiniMAXDEVICE

Total or Partial Hip Arthroplasty

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient with a clinical condition requiring THA 2. Patient receiving a MiniMAX® stem 3. Patient aged more than 18 years 4. Patient having a Social Insurance or a similar protection regime 5. Patient eligible for an AMIS procedure 6. Patient able to follow the study requirements 7. Patients who are willing to give informed written consent Exclusion Criteria: 1. Patient with local or systemic infection 2. Participation to biomedical research 3. Patient whose BMI exceeds 40 4. Patient with less than 18 years 5. Protected adults 6. Vulnerable person according to article L1121-6 of the Code de la Santè Publique. 7. Pregnant or lactating woman 8. Patient unable to express his/ her opinion about the participation to the study

Locations (1)

Centre Clinical Angouleme Soyaux

Soyaux, France, France

Outcomes

Primary Outcomes

Survival Rate

Kaplan Meier method

Time frame: 10 years

Secondary Outcomes

Functional evaluation

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.

Time frame: Pre-op, 3 months, 1, 3, 5, 10 years

Evaluation of patient satisfaction

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.

Time frame: Pre-op, 3 months, 1, 3, 5, 10 years

Evaluation of the stem fixation

Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.

Time frame: Pre-op, 3 months, 1, 3, 5, 10 years

Evaluation of the general and thigh pain

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.

Time frame: Pre-op, 3 months, 1, 3, 5, 10 years

Incidence of adverse events

Intraoperative and postoperative complications

Time frame: Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years

Data from ClinicalTrials.gov

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