PMCF Study of MOTIVATION HIP System in THA

NCT ID: NCT03892005

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed 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).

Conditions

Total Hip Arthroplasty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

MOTIVATION HIP Total Hip System

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.

Total Hip Arthroplasty using MOTIVATION HIP Total Hip System

Intervention Type: PROCEDURE

To systemically document the clinical safety and performance of the commercially available MOTIVATION HIP Total Hip System in primary THA.

Interventions

Total Hip Arthroplasty using MOTIVATION HIP Total Hip System

To systemically document the clinical safety and performance of the commercially available MOTIVATION HIP Total Hip System in primary THA.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuchang Zhu, Professor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Tenth Hospital

Locations

Shanghai Tenth Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CSA2018-04H

Identifier Type: -

Identifier Source: org_study_id