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

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

This is a post-marketing surveillance on MiniMAX Stem

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Avascular Necrosis; Congenital Hip Dysplasia; Primary Osteoarthritis; Secondary Osteoarthritis; Traumatic Arthritis; Fracture; Femur, Head
• Intervention / Treatment: Device: MiniMAX

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • France
    • Soyaux, France, France, 16800
      • Centre Clinical Angouleme Soyaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The sample size of 100 patients has been defined based on the literature data to guarantee a sufficient number of patients for the evaluation of the performance of the prosthesis, taking into account a 10% of lost patients (dead or lost at follow-up).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Rate	Kaplan Meier method	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Pre-op, 3 months, 1, 3, 5, 10 years
Incidence of adverse events	Intraoperative and postoperative complications	Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years
Evaluation of the stability of the stem	Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines.	Pre-op, 3 months, 1, 3, 5, 10 years

Collaborators and Investigators

• Sponsor: Medacta International SA

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): January 2, 2031

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Necrosis; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Developmental Dysplasia of the Hip; Fractures, Bone; Arthritis, Rheumatoid; Hip Dislocation, Congenital; Osteonecrosis
• Other Study ID Numbers: P01.005.10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No