PMCF Study of MOTIVATION HIP System in THA

Total Hip Arthroplasty Clinical Trial

Official title:

A Multi-Centre Post Market Clinical Follow-Up Study of MOTIVATION HIP Total Hip System in Total Hip Arthroplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03892005
• Other study ID #: CSA2018-04H
• Status: Enrolling by invitation
• Start date: July 1, 2021
• Est. completion date: December 31, 2032

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: December 31, 2032
• Est. primary completion date: June 30, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Shanghai Tenth Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	10 years
Secondary	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.	10 years
Secondary	Safety assessment	Summarize the category, incidence and frequency of adverse events	10 years