- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03892005
PMCF Study of MOTIVATION HIP System in THA
October 7, 2022 updated by: Zimmer Biomet
A Multi-Centre Post Market Clinical Follow-Up Study of MOTIVATION HIP Total Hip System in Total Hip Arthroplasty
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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).
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lydia Wang
- Phone Number: 6116 86-21-22206116
- Email: lydia.wang@zimmerbiomet.com
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China
- Recruiting
- Shanghai Tenth Hospital
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Contact:
- Yuchang Zhu, Professor
- Phone Number: 021-66301204
- Email: dyzhuyuchang@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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To systemically document the clinical safety and performance of the commercially available MOTIVATION HIP Total Hip System in primary THA.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant survivorship based on revision rate
Time Frame: 10 years
|
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).
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10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional outcome based on Harris Hip Score
Time Frame: 10 years
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Harris Hip Score is a clinician-based outcome measure consisting of 4 subscales.
The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4
points), and range of motion (5 points).
The scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
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10 years
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Quality of life based on EQ-5D questionnaire
Time Frame: 10 years
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EQ-5D is a standardized measure of health-related quality of life states consisting of 5 dimensions, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The EQ-5D-5L version was used in the study.
Each dimension has 5 responses recording 5 levels of severity (no problems/slight problems/moderate problems/severe problems or extreme problems).
The responses to the EQ-5D dimensions are used to obtain a single EQ-5D index value where 1 represents full health and 0 represents death.
The questionnaire also includes a vertical, visual analogue scale (EQ VAS) for the respondents to record their self-rated health where the 2 extreme ends of the scale are labelled as 'Best imaginable health state' and 'Worst imaginable health state' respectively.
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10 years
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Safety assessment
Time Frame: 10 years
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Summarize the category, incidence and frequency of adverse events
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10 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yuchang Zhu, Professor, Shanghai Tenth Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Anticipated)
June 30, 2032
Study Completion (Anticipated)
December 31, 2032
Study Registration Dates
First Submitted
March 8, 2019
First Submitted That Met QC Criteria
March 25, 2019
First Posted (Actual)
March 27, 2019
Study Record Updates
Last Update Posted (Actual)
October 13, 2022
Last Update Submitted That Met QC Criteria
October 7, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- CSA2018-04H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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