AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

Sponsor

Zimmer Biomet (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03357445

Collaborator

(none)

500

Enrollment

Locations

Arms

186.4

Anticipated Duration (Months)

125

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Osteoarthritis Post-Traumatic Arthritis Inflammatory Joint Disease Femoral Neck Fracture Femoral Head Necrosis Sequelae From Previous Hip Surgery Osteotomies Congenital Hip Dysplasia	Other: Avantage Reload cup	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 14, 2011

Anticipated Primary Completion Date :

Apr 27, 2027

Anticipated Study Completion Date :

Apr 27, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Subgroup 1 Prospective non Controlled to Document long term performance of AVANTAGE® RELOAD	Other: Avantage Reload cup Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty
Other: Subgroup 2 Randomized Controlled Trial to Evaluate wear rate of E1 liner in comparison to ArCom® liner	Other: Avantage Reload cup Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

Arm

Intervention/Treatment

Other: Subgroup 1

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

Other: Avantage Reload cup

Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

Other: Subgroup 2

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

Other: Avantage Reload cup

Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

Outcome Measures

Primary Outcome Measures

Survivorship [10 years post-surgery]
Implant survivorship

Secondary Outcome Measures

Harris hip scores [10 years post-surgery]
To measure clinical efficacy
EQ-5D [10 years post-surgery]
To measure clinical efficacy
Radiographic Evaluation [10 years post-surgery]
Abnormalities determined on X-rays in the bone region surrounding the implant will be reported (radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc)
Complications [10 years post-surgery]
Eventual complications occurred including dislocations and revisions/removals

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)