Total Hip ArthroplastyNCT03892005
PMCF Study of MOTIVATION HIP System in THA
An observational study of Total Hip Arthroplasty, run by Zimmer Biomet at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Total Hip Arthroplasty using MOTIVATION HIP Total Hip System
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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..
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Total Hip Arthroplasty using MOTIVATION HIP Total Hip System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip Arthroplasty using MOTIVATION HIP Total Hip SystemProcedure or surgery
To systemically document the clinical safety and performance of the commercially available MOTIVATION HIP Total Hip System in primary THA.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Total Hip Arthroplasty using MOTIVATION HIP Total Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 years
Secondary outcomes (3)
Functional outcome based on Harris Hip Score
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.
Measured: 10 years
Quality of life based on EQ-5D questionnaire
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.
Measured: 10 years
Safety assessment
Summarize the category, incidence and frequency of adverse events
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jul 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: No plan to extend CE Mark
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuchang Zhu, Professor, Principal investigator, Shanghai Tenth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892005
- Sponsor's protocol ID
- CSA2018-04H
- Status last verified
- Jul 2024
- First submitted
- 8 Mar 2019
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Post Market Clinical Follow-Up Study of MOTIVATION HIP Total Hip System in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03892005
- Acronym / sponsor ID
- CSA2018-04H
- Conditions
- Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: No plan to extend CE Mark
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOTIVATION HIP Total Hip System | – | Procedure: Total Hip Arthroplasty using MOTIVATION HIP Total Hip SystemAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- The patient is:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip Arthroplasty using MOTIVATION HIP Total Hip SystemTo systemically document the clinical safety and performance of the commercially available MOTIVATION HIP Total Hip System in primary THA. | Procedure or surgery | MOTIVATION HIP Total Hip System |
Primary outcome
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).
3 secondary outcomes
Functional outcome based on Harris Hip Score
Time frame: 10 years
Quality of life based on EQ-5D questionnaire
Time frame: 10 years
Safety assessment
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuchang Zhu, Professor principal investigator
Shanghai Tenth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty, run by Zimmer Biomet at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survivorship based on revision rate (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.