Clinical trial NCT04027140: MDR - M/L Taper With Kinectiv Technology Stems and Necks
Official title: 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: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hip Disease
Hip Fractures
Hip Injuries
Hip Arthritis
Hip Pain Chronic
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-07-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A consecutive series of subjects implanted with a M/L Taper with Kinectiv Technology Stem and or Neck according to the approved indications

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.

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
* 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

Primary outcomes:
measure: Device safety assessed through the frequency and incidence of revisions, complications and adverse events
timeFrame: Out to 10 Years.
measure: Device safety assessed through radiographic assessments
timeFrame: Out to 10 Years
Secondary outcomes:
measure: Device Performance and Benefits evaluated through the Harris Hip Score outcome measure.
timeFrame: Out to 10 Years
measure: Device Performance and Benefits evaluated through the EuroQolo Five Dimensions Questionnaire (EQ5D) outcome measure.
timeFrame: Out to 10 Years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Orthopedic and Fracture Specialists
state: Oregon
Study officials:
affiliation: Zimmer Biomet
name: Lynsey Boyle
role: STUDY_DIRECTOR
References: