Exceed ABT Acetabular Cup Cementless System

Rheumatoid Arthritis Clinical Trial

Official title:

A Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data on the Exceed ABT Acetabular Cementless Cup System (Implants and Instruments)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255394
• Other study ID #: BMETEU.CR.EU37
• Status: Completed
• Start date: July 1, 2010
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2022
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: March 31, 2022
• Est. primary completion date: February 28, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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'

Related Conditions & MeSH terms

• Correction of Functional Deformity
• Osteoarthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score	Clinical performance - as measured by clinical score data (HHS)	10 years
Primary	Western Ontario and McMasters Universities Osteoarthritis Index	Clinical performance - as measured by clinical score data - womac	10 yaers
Secondary	incidence of adverse events	Safety	10 years