AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Femoral Neck Fracture; Congenital Hip Dysplasia; Primary Osteoarthritis; Post-Traumatic Arthritis; Inflammatory Joint Disease; Femoral Head Necrosis; Sequelae From Previous Hip Surgery; Osteotomies
• Intervention / Treatment: Other: Avantage Reload 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 Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • CHU Côte de Nacre
  • Giens, France
    • Hôpital Renée Sabran
  • Montpellier, France
    • CHU Lapeyronie
• Slovenia
  • Novo Mesto, Slovenia
    • Hospital Novo Mesto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subgroup 1; Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD	Other: Avantage Reload cup; Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty
Other: Subgroup 2; Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner	Other: Avantage Reload cup; Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship	Implant survivorship	10 years post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Harris hip scores	To measure clinical efficacy	10 years post-surgery
EQ-5D	To measure clinical efficacy	10 years post-surgery
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
Complications	Eventual complications occurred including dislocations and revisions/removals	10 years post-surgery

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2011
• Primary Completion (Estimated): April 27, 2027
• Study Completion (Estimated): April 27, 2027

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: November 23, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Total hip Arthroplasty; Hip implant
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Musculoskeletal Diseases; Femoral Fractures; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Hip Fractures; Joint Diseases; Necrosis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Femoral Neck Fractures
• Other Study ID Numbers: BMETEU.CR.EU49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No