AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

• Register: ClinicalTrials.gov
• Last refreshed on: 9 October 2023
• Main ID: NCT03357445
• Date of registration: 23/11/2017
• Prospective Registration: No
• Primary sponsor: Zimmer Biomet
• Public title: AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
• Scientific title: Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes
• Date of first enrolment: October 14, 2011
• Target sample size: 500
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03357445
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

France, Slovenia, Spain

Contacts

• Name: Hassan Achakri
• Affiliation: Zimmer Biomet

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Joint Disease

Post-Traumatic Arthritis

Primary Osteoarthritis

Congenital Hip Dysplasia

Sequelae From Previous Hip Surgery

Femoral Head Necrosis

Femoral Neck Fracture

Osteotomies

Intervention(s)

Other: Avantage Reload cup

Primary Outcome(s)

Survivorship [Time Frame: 10 years post-surgery]

Secondary Outcome(s)

Harris hip scores [Time Frame: 10 years post-surgery]

Radiographic Evaluation [Time Frame: 10 years post-surgery]

Complications [Time Frame: 10 years post-surgery]

EQ-5D [Time Frame: 10 years post-surgery]

Secondary ID(s)

BMETEU.CR.EU49

Source(s) of Monetary Support

Please refer to primary and secondary sponsors