AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical... | NCT03357445

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2011Actual

Primary Completion Date

Apr 27, 2027Estimated

Completion Date

Apr 27, 2027Estimated

First Submitted Date

Nov 23, 2017

First Submission Date that Met QC Criteria

Nov 23, 2017

First Posted Date

Nov 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2024

Last Update Posted Date

Nov 14, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subgroup 1	Other	Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD	Other: Avantage Reload cup
Subgroup 2	Other	Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner	Other: Avantage Reload cup

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Avantage Reload cup	Other	Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty	Subgroup 1 Subgroup 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survivorship	Implant survivorship	10 years post-surgery

Secondary Outcomes

Measure	Description	Time Frame
Harris hip scores	To measure clinical efficacy	10 years post-surgery
EQ-5D	To measure clinical efficacy	10 years post-surgery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Hassan Achakri	Zimmer Biomet	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
CHU Cote de Nacre		Caen			France
Hôpital Renée Sabran

Masking Info

Masking

Single

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.

Who Masked

Participant

ID	Term
D005265	Femoral Neck Fractures
D006618	Hip Dislocation, Congenital

ID	Term
D006620	Hip Fractures
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries
D007869	Leg Injuries
D000082602	Developmental Dysplasia of the Hip
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities