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

Last updated: December 27, 2024
Sponsor: Zimmer Biomet
Overall Status: Terminated

Phase

N/A

Condition

Osteoporosis

Treatment

M/L Taper with Kinectiv Technology Stems and Necks

Clinical Study ID

NCT04027140
MDRG2017-89MS-56H
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 offollowing 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 forproper informed consent Patient is unwilling to sign the informed consent

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: M/L Taper with Kinectiv Technology Stems and Necks
Phase:
Study Start date:
January 22, 2020
Estimated Completion Date:
November 05, 2024

Study 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.

Connect with a study center

  • Orthopedic and Fracture Specialists

    Portland, Oregon 97225
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.