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Active, Not Recruiting

NCT Number: NCT06012656

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

This is a post-marketing surveillance on MiniMAX Stem

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Congenital Abnormalities Congenital Hip Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Developmental Dysplasia of the Hip Fracture; Femur, Head Fractures, Bone Hip Dislocation, Congenital Immune System Diseases Joint Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Secondary Osteoarthritis Skin and Connective Tissue Diseases Traumatic Arthritis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Clinical Angouleme Soyaux

Soyaux, France, 16800

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

MiniMAX

Device

Total or Partial Hip Arthroplasty

Primary outcomes

  1. Survival Rate

    Time frame: 10 years

    Kaplan Meier method

Secondary outcomes

  1. Functional evaluation

    Time frame: 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.

  2. Evaluation of patient satisfaction

    Time frame: 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.

  3. Evaluation of the stem fixation

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

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

  4. Evaluation of the general and thigh pain

    Time frame: 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.

  5. Incidence of adverse events

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

    Intraoperative and postoperative complications

  6. Evaluation of the stability of the stem

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

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

Sponsors and collaborators

Lead sponsor

Medacta International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2029
Study completion
2031
First posted
Aug 25, 2023
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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