AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

Not Applicable

Active, not recruiting

• Conditions: Primary Osteoarthritis; Femoral Head Necrosis; Congenital Hip Dysplasia; Post-Traumatic Arthritis; Femoral Neck Fracture; Osteotomies; Inflammatory Joint Disease; Sequelae From Previous Hip Surgery
• Interventions: Other: Avantage Reload cup

• Registration Number: NCT03357445
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-10-14
• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2017-11-23
• Study First Posted: 2017-11-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-14
• Primary Completion: 2027-04-27
• Study Completion: 2027-04-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subgroup 1	Avantage Reload cup	Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD
Subgroup 2	Avantage Reload cup	Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner

Primary Outcome Measures

Name	Time	Method
Survivorship	10 years post-surgery	Implant survivorship

Secondary Outcome Measures

Name	Time	Method
EQ-5D	10 years post-surgery	To measure clinical efficacy
Radiographic Evaluation	10 years post-surgery	Abnormalities determined on X-rays in the bone region surrounding the implant will be reported (radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc)
Harris hip scores	10 years post-surgery	To measure clinical efficacy
Complications	10 years post-surgery	Eventual complications occurred including dislocations and revisions/removals

Trial Locations

Locations (4)

CHU Cote de Nacre; 🇫🇷 Caen, France

CHU Lapeyronie; 🇫🇷 Montpellier, France

Hôpital Renée Sabran; 🇫🇷 Giens, France

Hospital Novo Mesto; 🇸🇮 Novo Mesto, Slovenia