AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-14

Study Completion Date

2027-04-27

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

The two subgroups will have the medical device with the following objectives:

Subgroup 1 Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD.

Subgroup 2 Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner.

Study Groups

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Subgroup 1

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

Group Type OTHER

Avantage Reload cup

Intervention Type OTHER

Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

Subgroup 2

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

Group Type OTHER

Avantage Reload cup

Intervention Type OTHER

Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

Interventions

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Avantage Reload cup

Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

Intervention Type OTHER

Eligibility Criteria

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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

* 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No