NCT03357445

Brief Summary

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

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Oct 2011Apr 2027

Study Start

First participant enrolled

October 14, 2011

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2027

Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

15.5 years

First QC Date

November 23, 2017

Last Update Submit

November 13, 2024

Conditions

Primary OsteoarthritisPost-Traumatic ArthritisInflammatory Joint DiseaseFemoral Neck FractureFemoral Head NecrosisSequelae From Previous Hip SurgeryOsteotomiesCongenital Hip Dysplasia

Keywords

Total hip ArthroplastyHip implant

Outcome Measures

Primary Outcomes (1)

  • Survivorship

    Implant survivorship

    10 years post-surgery

Secondary Outcomes (4)

  • Harris hip scores

    10 years post-surgery

  • EQ-5D

    10 years post-surgery

  • Radiographic Evaluation

    10 years post-surgery

  • Complications

    10 years post-surgery

Study Arms (2)

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

Avantage Reload cupOTHER

Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

Subgroup 1Subgroup 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Male or female
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Cote de Nacre

Caen, France

Location

Hôpital Renée Sabran

Giens, France

Location

CHU Lapeyronie

Montpellier, France

Location

Hospital Novo Mesto

Novo Mesto, Slovenia

Location

MeSH Terms

Conditions

Femoral Neck FracturesHip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesDevelopmental Dysplasia of the HipMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Hassan Achakri

    Zimmer Biomet

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2017

First Posted

November 29, 2017

Study Start

October 14, 2011

Primary Completion (Estimated)

April 27, 2027

Study Completion (Estimated)

April 27, 2027

Last Updated

November 14, 2024

Record last verified: 2024-11

Locations

FR(3)SL(1)