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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06012656
• Other study ID #: P01.005.10
• Status: Active, not recruiting
• Start date: January 2, 2019
• Est. completion date: January 2, 2031

Study information

• Verified date: July 2023
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a post-marketing surveillance on MiniMAX Stem

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2, 2031
• Est. primary completion date: January 2, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis
• Primary Osteoarthritis
• Rheumatoid Arthritis
• Secondary Osteoarthritis
• Traumatic Arthritis

Intervention

Device:
• MiniMAX
Total or Partial Hip Arthroplasty

Locations

Country	Name	City	State
France	Centre Clinical Angouleme Soyaux	Soyaux

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Rate	Kaplan Meier method	10 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of adverse events	Intraoperative and postoperative complications	Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years
Secondary	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