Vivacit-E Post-market Follow-up Study

Osteoarthritis Clinical Trial

Official title:

Post Market Clinical Follow-up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner Used With the Continuum Acetabular Shell

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03226808
• Other study ID #: CMU2011-09H
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2013
• Est. completion date: June 30, 2028

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported adverse events data.

Description:

Safety will be evaluated by monitoring the frequency and incidence of adverse events. Performance will be determined by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Vivacit-E HXPE Liner with the Continuum acetabular shell. In addition, the implanted Vivacit-E HXPE Liners will be evaluated for bedding in, and linear and volumetric wear by the Martell 2-D method at 6 weeks and 1, 2, 4, & 5 years postoperatively. Pain and functional performance will be measured using the Harris Hip and High Activity Arthroplasty Scores. Survivorship will be based on removal or intended removal of the device and through analysis of radiographs, and health status will be determined by evaluation of the EQ-5D.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 258
• Est. completion date: June 30, 2028
• Est. primary completion date: March 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patient is 18 to 60 years of age, inclusive.
• Patient is skeletally mature.
• Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA)

based on physical exam and medical history including at least one of the following:

• Osteoarthritis
• Avascular necrosis (AVN)
• Post-traumatic arthritis
• Congenital hip dysplasia
• Patient has no history of previous total hip replacement or arthrodesis of the affected hip joint(s).
• Patient is willing and able to provide written informed consent.
• Patient is willing and able to cooperate in the required post-operative therapy.
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
• Patient has participated in the Informed Consent process and has signed the IRB/EC approved informed consent.

Exclusion Criteria:

• Patient is unwilling or unable to give consent or to comply with the follow-up program.
• Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc. in the affected hip joint(s).
• Inflammatory Arthritis
• Rheumatoid Arthritis
• The patient is:
• a prisoner mentally incompetent or unable to understand what participation in the study entails a known alcohol or drug abuser
• anticipated to be non-compliant
• The patient has an acute, chronic, or systemic infection(s).
• The patient has total or partial absence of the muscular or ligamentous apparatus.
• The patient has neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation.
• The patient has osteoradionecrosis.
• The patient has lack of bony structures proximal or distal to the operative joint, so that good implant fixation is unlikely or impossible.
• The patient has local bone tumors/cysts in the bone to be retained that the implanting surgeon determines could inhibit implant fixation.
• The patient is skeletally immature.
• The patient has any concomitant disease that can jeopardize the functioning and the success of the implant.
• The patient is known to be pregnant.
• The patient has a known sensitivity or allergic reaction to one or more of the implanted materials which include metal (titanium, tivanium, tantalum, cobalt, chromium, nickel) and ceramic.

Related Conditions & MeSH terms

• Avascular Necrosis of Bone of Hip
• Congenital Hip Dysplasia
• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Osteoarthritis
• Osteonecrosis
• Post-traumatic; Arthrosis

Intervention

Device:
• Vivacit-E Liner
All subjects enrolled will receive the Vivacit-E liner.

Locations

Country	Name	City	State
United States	Texas Institute for Hip and Knee Surgery	Austin	Texas
United States	Department of Orthopaedics University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	OrthoCarolina Research Institute	Charlotte	North Carolina
United States	Denver Hip and Knee, Inc.	Parker	Colorado
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of the study device; whether or not it is still implanted in the subject	Survival is classified as removal of the study device for any reason	10 years
Secondary	Incidence of treatment-emergent Adverse Events (safety)	Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.	10 years
Secondary	Harris Hip Score	Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction.	10 years
Secondary	Patient activity level	Patient activity level is assessed with the High Activity Arthroplasty score, filled out by the patient.	10 years
Secondary	Patient Quality of Life	This is another self-assessment by means of the EQ-5D score, which measures the patient's perceived quality of life.	10 years
Secondary	Radiographic analysis	Patient x-rays will undergo a Martell analysis by Dr. John Martell to evaluate radiolucencies, osteolysis, sbusidence, cup migration and polyethylene wear.	2 years