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

Active, not recruiting

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

• Registration Number: NCT06012656
• Lead Sponsor: Medacta International SA

Brief Summary

This is a post-marketing surveillance on MiniMAX Stem

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Status Verified: 2023-07
• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-25
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-01
• Primary Completion: 2029-01-02
• Study Completion: 2031-01-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival Rate	10 years	Kaplan Meier method

Secondary Outcome Measures

Name	Time	Method
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.
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.
Incidence of adverse events	Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years	Intraoperative and postoperative complications
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 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.
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.

Trial Locations

Locations (1)

Centre Clinical Angouleme Soyaux; 🇫🇷 Soyaux, France