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

Overview

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 Title of Study: “Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the M/L Taper With Kinectiv Technology Stems and Necks”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: January 22, 2024

Detailed 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.

Interventions

• Device: 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.

Clinical Trial Outcome Measures

Primary Measures

• Device safety assessed through the frequency and incidence of revisions, complications and adverse events
  • Time Frame: Out to 10 Years.
  • The primary objective of this study is the assessment of the safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to either implant or instrumentation should be specified.
• Device safety assessed through radiographic assessments
  • Time Frame: Out to 10 Years
  • The primary objective of this study is to assess the safety of the device by reviewing radiographic data post implantation for each patient. A radiograph will be taken at each follow-up time point and reviewed by the surgeon to assess the frequency and incidence of any device related issues that may show up.

Secondary Measures

• Device Performance and Benefits evaluated through the Harris Hip Score outcome measure.
  • Time Frame: Out to 10 Years
  • The HHS is divided into 4 sub-categories; pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). Patients select a discrete set of answers which correspond to predefined point allocations based on the category. To obtain a final score, these values are summed.
• Device Performance and Benefits evaluated through the EuroQolo Five Dimensions Questionnaire (EQ5D) outcome measure.
  • Time Frame: Out to 10 Years
  • The EQ-5D measures 5 dimensions of general health; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a total of 5 questions. It is accompanied by the patient’s self-assessment with the VAS. There are three versions of the EQ-5D; 3 level (3L), 5 level (5L), and a youth (Y) version based off of the 3L model. Each dimension is assigned one of three discrete levels for evaluation on the day of administration for the three level evaluation: Level 1 – No problems, no disability Level 2 – Some problems, moderate disability Level 3 – A lot of problems, severe disability The final score is a five digit composite of the responses ranging between 33333 – 11111 with 243 possible combinations in between for the 3L test. The 5L test can measure 3,125 different health states and ranges between 55555-11111.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Zimmer Biomet
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Jarrod Hunnicutt, Study Director, Zimmer Biomet
• Overall Contact(s)
  • Richard Marek, 574-453-7567, richard.marek@zimmerbiomet.com