Back to resultsAVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
Primary Purpose
Primary Osteoarthritis, Post-Traumatic Arthritis, Inflammatory Joint Disease
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Avantage Reload cup
Sponsored by
About this trial
This is an interventional other trial for Primary Osteoarthritis focused on measuring Total hip Arthroplasty, Hip implant
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
Sites / Locations
- CHU Cote de Nacre
- Hôpital Renée Sabran
- CHU Lapeyronie
- Hospital Novo Mesto
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Subgroup 1
Subgroup 2
Arm Description
Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD
Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner
Outcomes
Primary Outcome Measures
Survivorship
Implant survivorship
Secondary Outcome Measures
Harris hip scores
To measure clinical efficacy
EQ-5D
To measure clinical efficacy
Radiographic Evaluation
Abnormalities determined on X-rays in the bone region surrounding the implant will be reported (radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc)
Complications
Eventual complications occurred including dislocations and revisions/removals
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03357445
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2011 (Actual)
Primary Completion Date
April 27, 2027 (Anticipated)
Study Completion Date
April 27, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subgroup 1
Arm Type
Other
Arm Description
Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD
Arm Title
Subgroup 2
Arm Type
Other
Arm Description
Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner
Intervention Type
Other
Intervention Name(s)
Avantage Reload cup
Intervention Description
Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty
Primary Outcome Measure Information:
Title
Survivorship
Description
Implant survivorship
Time Frame
10 years post-surgery
Secondary Outcome Measure Information:
Title
Harris hip scores
Description
To measure clinical efficacy
Time Frame
10 years post-surgery
Title
EQ-5D
Description
To measure clinical efficacy
Time Frame
10 years post-surgery
Title
Radiographic Evaluation
Description
Abnormalities determined on X-rays in the bone region surrounding the implant will be reported (radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc)
Time Frame
10 years post-surgery
Title
Complications
Description
Eventual complications occurred including dislocations and revisions/removals
Time Frame
10 years post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Achakri
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
CHU Cote de Nacre
City
Caen
Country
France
Facility Name
Hôpital Renée Sabran
City
Giens
Country
France
Facility Name
CHU Lapeyronie
City
Montpellier
Country
France
Facility Name
Hospital Novo Mesto
City
Novo Mesto
Country
Slovenia
12. IPD Sharing Statement
Learn more about this trial
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
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