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

Zimmer Biomet

Status: Enrolling

Conditions: Hip Injuries; Hip Fractures; Hip Disease; Hip Arthritis; Hip Pain Chronic

Treatments: Device: M/L Taper with Kinectiv Technology Stems and Necks

Study type: Observational

Funder types: Industry

Identifiers

NCT04027140

MDRG2017-89MS-56H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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