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

NCT06012656 | Active Not Recruiting

• 1 other identifier: P01.005.10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a post-marketing surveillance on MiniMAX Stem

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Survival Rate

  Kaplan Meier method

  10 years

Secondary Outcomes (6)

• Functional evaluation

  Pre-op, 3 months, 1, 3, 5, 10 years

• Evaluation of patient satisfaction

  Pre-op, 3 months, 1, 3, 5, 10 years

• Evaluation of the stem fixation

  Pre-op, 3 months, 1, 3, 5, 10 years

• Evaluation of the general and thigh pain

  Pre-op, 3 months, 1, 3, 5, 10 years

• Incidence of adverse events

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

Interventions

MiniMAX DEVICE

Total or Partial Hip Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (1)

Centre Clinical Angouleme Soyaux

Soyaux, France, 16800, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Hip Dislocation, Congenital; Osteonecrosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 25, 2023
• Study Start: January 2, 2019
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): January 2, 2031
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)