Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03357445
Other study ID # BMETEU.CR.EU49
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT02139345 - TC-A Registration Study N/A
Completed NCT00487565 - Clinical Investigation of the LCS® Complete Posterior Stabilized Mobile-bearing Total Knee System N/A
Terminated NCT00872547 - Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement Phase 4
Completed NCT00586781 - Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease Phase 3
Active, not recruiting NCT03343171 - Continuum Ceramic on Ceramic Bearing Post Market Clinical Follow-Up Study
Completed NCT00503438 - Ankle Joint Replacement Outcomes Study
Terminated NCT00764894 - Foundation Knee Study - Retrospective Phase 4
Terminated NCT00492219 - Postoperative Function Following Partial and Total Knee Replacement N/A
Terminated NCT00208403 - A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement Phase 4
Completed NCT02574312 - ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty N/A
Terminated NCT00839020 - Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA) Phase 4
Terminated NCT00872794 - A Single Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery Phase 4
Completed NCT00764530 - Cementless Alumina-Alumina Total Hip and Hybrid N/A
Terminated NCT00306917 - Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement N/A
Terminated NCT00208351 - A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement Phase 3
Terminated NCT01657435 - 28mm Ceramic-on-Ceramic Total Hip Replacement Study
Active, not recruiting NCT01307384 - Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study
Completed NCT00872066 - A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement Phase 4
Completed NCT00289094 - Randomized Fixed Bearing vs Mobile Bearing Cruciate Retaining TKA N/A
Recruiting NCT02469662 - Clinical Outcomes Study of the Nexel Total Elbow N/A