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NCT03357445 Clinical Trial

AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

Post-Traumatic Arthritis Clinical Trial

Official title:
Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03357445
Other study ID # BMETEU.CR.EU49
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 14, 2011
Est. completion date April 27, 2027

Study information
Verified date September 2023
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.

Description:

The study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the AVANTAGE RELOAD cup. Secondary objective is to evaluate the polyethylene wear between E1 and ARCOM. 500 patients was the enrollment goal with 2 subgroups. - Subgroup 1: prospective and non-controlled to satisfy ODEP (Orthopedic Device Evaluation Panel) requirements; - Subgroup 2: randomized and controlled to compare the polyethylene wear between the Arcom and the E1 liners.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date April 27, 2027
Est. primary completion date April 27, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically - Primary osteoarthritis - Post-Traumatic arthritis - Inflammatory joint disease (e.g. Rheumatoid arthritis) - Femoral neck fracture - Femoral head necrosis - Sequelae from previous hip surgery, osteotomies, etc. - Congenital hip dysplasia Additional inclusion criteria include: - Male or female - 18 years of age or older - Subjects willing to return for follow-up evaluations - Subjects who read, understand study information and give written consent (specific local regulatory requirements) Exclusion Criteria: - Exclusion criteria should be in accordance with Contraindications for the AVANTAGE® RELOAD: Absolute contraindications include: - Infection - Sepsis - Severe muscular, neurological or vascular deficiencies of the extremity involved - Bone destruction or poor bone quality Additional contraindications include: - Subjects unable to co-operate with and complete the study - Dementia and inability to understand and follow instructions - Neurological conditions affecting movement - Patient over 18 under law supervision

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Avantage Reload cup
Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

Locations
Country Name City State
France CHU Cote de Nacre Caen
France Hôpital Renée Sabran Giens
France CHU Lapeyronie Montpellier
Slovenia Hospital Novo Mesto Novo Mesto

Sponsors (1)
Lead Sponsor Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

France,  Slovenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survivorship Implant survivorship 10 years post-surgery
Secondary Harris hip scores To measure clinical efficacy 10 years post-surgery
Secondary EQ-5D To measure clinical efficacy 10 years post-surgery
Secondary Radiographic Evaluation Abnormalities determined on X-rays in the bone region surrounding the implant will be reported (radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc) 10 years post-surgery
Secondary Complications Eventual complications occurred including dislocations and revisions/removals 10 years post-surgery
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