Avascular Necrosis, Congenital Hip Dysplasia, Fracture; Femur, Head, Primary Osteoarthritis, Rheumatoid Arthritis, Secondary Osteoarthritis, Traumatic Arthritis
Conditions
Brief summary
This is a post-marketing surveillance on MiniMAX Stem
Interventions
DEVICEMiniMAX
Total or Partial Hip Arthroplasty
Sponsors
Medacta International SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate | 10 years | Kaplan Meier method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
France
Outcome results
None listed