MDR Vivacit-E Elevated Study

• 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

• Registration Number: NCT07150221
• Lead Sponsor: Zimmer Biomet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-29
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-02
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival of the Implant System via Adverse Events	10 years	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.

Secondary Outcome Measures

Name	Time	Method
Pain measured by the Oxford Hip Score	10 years
functional performance measured by the Oxford Hip Score	10 years
Subject quality-of-life measured by the EQ-5D-5L	10 Years

Trial Locations

Locations (1)

South Bend Orthopaedics; 🇺🇸 South Bend, Indiana, United States