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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hip Disease
- Sponsor
- Zimmer Biomet
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Device safety assessed through the frequency and incidence of revisions, complications and adverse events
- Status
- Terminated
- Last Updated
- last year
Overview
Brief 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.
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.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
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 Outcomes
- Device Performance and Benefits evaluated through the Harris Hip Score outcome measure.(Out to 10 Years)
- Device Performance and Benefits evaluated through the EuroQolo Five Dimensions Questionnaire (EQ5D) outcome measure.(Out to 10 Years)