Clinical trial NCT03357445: AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
Official title: Prospective, Multi Centre Evaluation of AVANTAGE® RELOAD Double Mobility Acetabular Cup - Clinical and Radiographic Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Osteoarthritis
Post-Traumatic Arthritis
Inflammatory Joint Disease
Femoral Neck Fracture
Femoral Head Necrosis
Sequelae From Previous Hip Surgery
Osteotomies
Congenital Hip Dysplasia
Keywords: Total hip Arthroplasty
Hip implant
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-11-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Survivorship
timeFrame: 10 years post-surgery
Secondary outcomes:
measure: Harris hip scores
timeFrame: 10 years post-surgery
measure: EQ-5D
timeFrame: 10 years post-surgery
measure: Radiographic Evaluation
timeFrame: 10 years post-surgery
measure: Complications
timeFrame: 10 years post-surgery
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Cote de Nacre
city: Giens
country: France
facility: Hôpital Renée Sabran
city: Montpellier
country: France
facility: CHU Lapeyronie
city: Novo Mesto
country: Slovenia
facility: Hospital Novo Mesto
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: