Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04027140
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Lynsey Boyle
Principal Investigator Affiliation Zimmer Biomet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hip Disease, Hip Fractures, Hip Injuries, Hip Arthritis, Hip Pain Chronic
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Orthopedic and Fracture Specialists, Portland, Oregon

Status

Recruiting

Address

Orthopedic and Fracture Specialists

Portland, Oregon, 97225

Site Contact

Erin Zimmerman, BA

[email protected]

503-214-5259

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