AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

Zimmer Biomet

Status: Active, not recruiting

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

Treatments: Other: Avantage Reload cup

Study type: Interventional

Funder types: Industry

Identifiers

NCT03357445

BMETEU.CR.EU49

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Subgroup 1

Other group

Description:

Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD

Treatment:

Other: Avantage Reload cup

Subgroup 2

Other group

Description:

Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner

Treatment:

Other: Avantage Reload cup