MDR Vivacit-E Elevated Study

NCT07150221 | Enrolling By Invitation FDA Device

• 1 other identifier: MDRG2017-89MS-106H
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty.

Conditions

Osteoarthritis (OA) of the Hip; Avascular Necrosis of Bone of Hip; Protrusio Acetabuli; Traumatic Arthropathy-Hip; Slipped Capital Femoral Epiphyses; Fused Hip; Fracture of Pelvis; Diastrophic Variant

Outcome Measures

Primary Outcomes (1)

• Survival of the Implant System via Adverse Events

  The primary endpoint is defined by the survival of the implant system at 10 years post-operative, which is based on removal of the study device and will be determined using the Kaplan Meier method. The safety of the study device will be assessed by monitoring the frequency and incidence of adverse events.

  10 years

Secondary Outcomes (2)

• Pain and functional performance measured by the Oxford Hip Score

  10 years

• Subject quality-of-life measured by the EQ-5D-5L

  10 Years

Study Arms (1)

Vivacit-E Elevated Liners

Patients previously implanted with Vivacit-E Elevated Liners.

Device: Vivacit-E Elevated Liners

Interventions

Vivacit-E Elevated Liners DEVICE

Primary total hip arthroplasty

Vivacit-E Elevated Liners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population should consist of a maximum of 52 subjects implanted 10 years ago with the Vivacit-E Vitamin E HXLPE Elevated Liner in total hip arthroplasty, according to the approved indications.

You may qualify if:

• Patient was 18 years of age or older and skeletally mature at the time of surgery
• Patient qualified for and underwent surgical procedure with a Vivacit-E Vitamin E HXLPE Elevated Liner to treat one of the following indications in primary THA:
• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Protrusio acetabuli
• Traumatic arthritis
• Slipped capital epiphysis
• Fused hip
• Fracture of the pelvis
• Diastrophic variant
• Patient underwent surgical procedure 10 years (+ no maximum/- 182 days) prior to date of study consent
• Patient is will and able to sign IRB approved Informed Consent Form or provide verbal consent

You may not qualify if:

• Off label use or not according to the approved IFU at the time of surgery
• Patient presented with any of the following at the time of the surgical procedure:
• Osteoradionecrosis
• Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
• Systemic or local infection
• Revision procedure where other treatment or devices have failed\*
• Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
• Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
• For the purpose of this clinical study; a revision procedure refers to a procedure in which the prior procedure on the ipsilateral hip utilized a similar approach (i.e., primary total hip arthoplasty)

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

South Bend Orthopaedics

South Bend, Indiana, 46635, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Slipped Capital Femoral Epiphyses; Hip Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Epiphyses, Slipped; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: September 2, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)