PMCF Study of MOTIVATION HIP System in THA

Zimmer Biomet

Status: Suspended

Conditions: Total Hip Arthroplasty

Treatments: Procedure: Total Hip Arthroplasty using MOTIVATION HIP Total Hip System

Study type: Observational

Funder types: Industry

Identifiers

NCT03892005

CSA2018-04H

Details and patient eligibility

About

This is a retrospective and prospective, multi-center, post-market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the study device system.

Full description

The objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available MOTIVATION HIP Total Hip System used in primary total hip arthroplasty (THA).

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 75 years old, inclusive.
• Had a primary unilateral or bilateral (simultaneous or staged) THA based on physical exam and medical history, including diagnosis of severe hip pain and disability.
• Had received MOTIVATION HIPTM Total Hip System per the approved indications for use for the THA.
• No history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joint(s) beside investigational product.
• Willing and able to provide written informed consent by signing and dating the EC approved informed consent form.
• Willing and able to complete scheduled follow-up evaluations..

Exclusion criteria

• 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

    • Has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure or complications in postoperative care.
    • Has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
    • Has a diagnosed systemic disease that could affect his/her safety or the study outcome.
    • Known to be pregnant.
    • Has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
    • Insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e., osteoporosis), cancer, and radiation.
    • Osteoradionecrosis in the affected hip joint.
    • Known sensitivity or allergic reaction to one or more of the implanted materials.
    • Known local bone tumors and/or cysts in the operative hip.
    • Body Mass Index (BMI) > 40.

Trial design

500 participants in 1 patient group

MOTIVATION HIP Total Hip System

Description:

All study subjects have undergone routine preoperative clinical evaluations prior to their THA, and implanted MOTIVATION HIPTM Total Hip System in accordance to indications and intended use, and appropriate surgical technique(s) will be invited to participate in the study at their first year of postoperative follow up visit, and sign ICF.

Treatment:

Procedure: Total Hip Arthroplasty using MOTIVATION HIP Total Hip System