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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-22

Study Completion Date

2024-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Disease Hip Fractures Hip Injuries Hip Arthritis Hip Pain Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

M/L Taper with Kinectiv Technology Stems and Necks

Patients that have been implanted with a M/L Taper with Kinectiv Technology Stem and/or neck to repair hip malfunction/disease.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lynsey Boyle

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Orthopedic and Fracture Specialists

Portland, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MDRG2017-89MS-56H

Identifier Type: -

Identifier Source: org_study_id