Exceed ABT Acetabular Cup Cementless System

NCT ID: NCT04255394

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 677 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-01
• Study Completion Date: 2022-03-31

Brief Summary

A Post-market Clinical Follow-up Study to provide safety, performance and clinical benefits data on the Exceed ABT acetabular cup (implants and instruments) when used in combination with ceramic liners or polyethylene articulating liners bearing Options.

A single-center, cohort observational clinical outcomes study

Detailed Description

Study Aim: To collect survivorship and clinical outcomes long-term data confirm-ing safety, performance and clinical benefits of the Exceed ABT ce-mentless cup when used in combination with ceramic and polyeth-ylene articulating liners

Objectives: Primary Objectives:

Clinical performance - as measured by clinical score data (HHS, WOMAC and Oxford Hip Score), radiographic as-sessments and survivorship which will be based on removal of the device.

Secondary Objectives:

Safety will be evaluated by monitoring incidence of adverse events. Length of study: 13 years (3 years enrollment plus 10 years follow-up): Post-operative follow-up visits at: 1, 3, 5, 7 and 10 years

Conditions

Osteoarthritis; Rheumatoid Arthritis; Correction of Functional Deformity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program
• Patient who gave verbal consent to take part in the study at study commencement and written consent retrospectively at 10 years follow-up by signing the informed consent form according to the General data protection Regulation (GDPR) Patient Consent Form"
• Age: => 18 years
• Male and Female
• Non- inflammatory degenerative joint disease including osteoarthritis, avascular necrosis & post traumatic arthritis
• Rheumatoid arthritis,
• Correction of functional deformity
• Revision of failed joint reconstruction or treatment
• Treatment of femoral neck and trochanteric fractures of the proximal femur with femoral head involvement and which are unmanageable using other techniques

Exclusion Criteria

• Infection, sepsis, and osteomyelitis
• Patients who are unwilling or unable to give consent, or to comply with the follow-up program
• The patient is known to be pregnant or breastfeeding
• Any vulnerable subjects (= individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate)
• Uncooperative patient or patient with neurologic disorders who are incapable of fol-lowing instruction
• Osteoporosis
• Metabolic disorder which may impair bone formation
• Osteomalacia
• Local and distant foci of infection
• Rapid joint destruction, marked bone loss or bone resorption apparent on roent-genogram
• Vascular insufficiency, muscular atrophy, or neuromuscular disease
• Skeletal immaturity
• Morbid obesity
• Foreign body sensitivity. Where suspected, material sensitivity tests are to be made prior to implantation
• Any condition that may interfere with the survival of the implant such as Paget's disease, Charcot's disease, sickle cell anaemia or traits, lower extremity muscular atrophy or neuromuscular disease'

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BMETEU.CR.EU37

Identifier Type: -

Identifier Source: org_study_id