Clinical trial NCT03892005: PMCF Study of MOTIVATION HIP System in THA
Official title: A Multi-Centre Post Market Clinical Follow-Up Study of MOTIVATION HIP Total Hip System in Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Total Hip Arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-03-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Implant survivorship based on revision rate
timeFrame: 10 years
Secondary outcomes:
measure: Functional outcome based on Harris Hip Score
timeFrame: 10 years
measure: Quality of life based on EQ-5D questionnaire
timeFrame: 10 years
measure: Safety assessment
timeFrame: 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Tenth Hospital
name: Yuchang Zhu, Professor
role: PRINCIPAL_INVESTIGATOR
References: