PMCF Study of MOTIVATION HIP System in THA

NCT03892005 | Suspended

• 1 other identifier: CSA2018-04H
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Implant survivorship based on revision rate

  Implant survivorship will be assessed using a Kaplan-Meier analysis. Data will be considered right-censored for all subjects that do not have a device related failed. For subjects who are lost-to-follow up, their last available clinical visit will be considered as the censored date. For subjects who died during the study, their death date will be used as the censored date. The survivorship point estimate and 95% confidence interval about the point estimate will be calculated for each follow up visit (1 year, 2 years, 3 years, 5 years, 7 years and 10 years).

  10 years

Secondary Outcomes (3)

• Functional outcome based on Harris Hip Score

  10 years

• Quality of life based on EQ-5D questionnaire

  10 years

• Safety assessment

  10 years

Study Arms (1)

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.

Procedure: Total Hip Arthroplasty using MOTIVATION HIP Total Hip System

Interventions

Total Hip Arthroplasty using MOTIVATION HIP Total Hip System PROCEDURE

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

MOTIVATION HIP Total Hip System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population are patients who have received MOTIVATION HIPTM Total Hip System for their primary THA and meet the Patient Selection Criteria outlined in the protocol.

You may qualify if:

• 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..

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Shanghai Tenth Hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Yuchang Zhu, Professor

  Shanghai Tenth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 27, 2019
• Study Start: July 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)