MDR - M/L Taper With Kinectiv Technology Stems and Necks

  • STATUS
    Recruiting
  • End date
    Jan 22, 2024
  • participants needed
    164
  • sponsor
    Zimmer Biomet
Updated on 6 September 2021
hip arthroplasty
femoral neck fracture

Summary

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip arthroplasty (implants) at 1,2,5 and 10-year follow-up*. ML Taper with Kinectiv Technology has been on the market since 2008, but has insufficient long term clinical data. Therefore, a prospective aspect to the study will be necessary to reach the 10-year time point.

Description

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip arthroplasty (implants) at 1,2,5 and 10-year follow-up*. ML Taper with Kinectiv Technology has been on the market since 2008, but has insufficient long term clinical data. Therefore, a prospective aspect to the study will be necessary to reach the 10-year time point.

The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.

The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).

*Follow-up with the patient at the 10 year time point will be collected by the site prospectively and the 1, 2 and 5 year time point data will be collected by the sponsor retrospectively from an existing database including ML Taper with Kinectiv Technology patients from a Zimmer Biomet hip registry.

Details
Condition Hip Disease, Wounds, Hip Pain Chronic, hip fractures, Hip Arthritis, Trauma, arthritis hip, broken hip, HIP FRACTURE, Hip Injury
Treatment M/L Taper with Kinectiv Technology Stems and Necks
Clinical Study IdentifierNCT04027140
SponsorZimmer Biomet
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient must be 18 years of age or older
Rheumatoid arthritis
Osteoarthritis
Traumatic arthritis
Polyarthritis
Collagen disorders
Avascular necrosis of the femoral head
Nonunion of previous fractures of the femur
Acute femoral neck fractures
Congenital hip dysplasia
Protrusio acetabuli
Previously failed endoprostheses
Patient must be willing and able to sign IRB/EC approved informed consent

Exclusion Criteria

Skeletal immaturity
Loss of abductor musculature in the affected limb
Poor bone stock (e.g., steroid-induced metabolic bone disease)
Poor skin coverage around the hip joint
Neuromuscular disease (e.g., Charcot's joint) in the affected limb
Local and/or overt systemic infection
Patient with a stove-pipe femur
Stem implanted using cement fixation
Off-label use
Uncooperative patient or patient with neurologic disorders who are incapable of following directions
Patient is known to be pregnant or nursing
Patient is a prisoner
Patient is a known alcohol or drug abuser
Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent Patient is unwilling to sign the informed consent
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note