AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

Post-Traumatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03357445
• Other study ID #: BMETEU.CR.EU49
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 14, 2011
• Est. completion date: April 27, 2027

Study information

• Verified date: September 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: April 27, 2027
• Est. primary completion date: April 27, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Femoral Head Necrosis
• Femoral Neck Fracture
• Femoral Neck Fractures
• Hip Dislocation
• Hip Dislocation, Congenital
• Inflammatory Joint Disease
• Joint Diseases
• Necrosis
• Osteotomies
• Post-Traumatic Arthritis
• Primary Osteoarthritis
• Sequelae From Previous Hip Surgery

Intervention

Other:
• Avantage Reload cup
Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

Locations

Country	Name	City	State
France	CHU Cote de Nacre	Caen
France	Hôpital Renée Sabran	Giens
France	CHU Lapeyronie	Montpellier
Slovenia	Hospital Novo Mesto	Novo Mesto

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

France,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship	Implant survivorship	10 years post-surgery
Secondary	Harris hip scores	To measure clinical efficacy	10 years post-surgery
Secondary	EQ-5D	To measure clinical efficacy	10 years post-surgery
Secondary	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
Secondary	Complications	Eventual complications occurred including dislocations and revisions/removals	10 years post-surgery