Total Hip Arthroplasty
Conditions
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).
Interventions
PROCEDURETotal 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.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant survivorship based on revision rate | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome based on Harris Hip Score | 10 years | 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. |
| Quality of life based on EQ-5D questionnaire | 10 years | 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. |
| Safety assessment | 10 years | Summarize the category, incidence and frequency of adverse events |
Countries
China
Outcome results
None listed