Clinical trial NCT03226808: Vivacit-E Post-market Follow-up Study
Official title: Post Market Clinical Follow-up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner Used With the Continuum Acetabular Shell
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Avascular Necrosis of Bone of Hip
Post-traumatic; Arthrosis
Congenital Hip Dysplasia
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-07-24
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival of the study device; whether or not it is still implanted in the subject
timeFrame: 10 years
Secondary outcomes:
measure: Incidence of treatment-emergent Adverse Events (safety)
timeFrame: 10 years
measure: Harris Hip Score
timeFrame: 10 years
measure: Patient activity level
timeFrame: 10 years
measure: Patient Quality of Life
timeFrame: 10 years
measure: Radiographic analysis
timeFrame: 2 years
Other outcomes:
Locations:
city: Parker
country: United States
facility: Denver Hip and Knee, Inc.
state: Colorado
city: Chapel Hill
country: United States
facility: Department of Orthopaedics University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Austin
country: United States
facility: Texas Institute for Hip and Knee Surgery
state: Texas
Study officials:
affiliation: Zimmer Biomet
name: Ryan Boylan, MBA
role: STUDY_DIRECTOR
References: