MDR Vivacit-E Elevated Study

Zimmer Biomet

Status: Invitation-only

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

Treatments: Device: Vivacit-E Elevated Liners

Study type: Observational

Funder types: Industry

Identifiers

NCT07150221

MDRG2017-89MS-106H

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

52 participants in 1 patient group

Vivacit-E Elevated Liners

Description:

Patients previously implanted with Vivacit-E Elevated Liners.

Treatment:

Device: Vivacit-E Elevated Liners