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

NCT04027140 | Terminated FDA Device

• 1 other identifier: MDRG2017-89MS-56H
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Device safety assessed through the frequency and incidence of revisions, complications and adverse events

  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.

  Out to 10 Years.

• Device safety assessed through radiographic assessments

  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.

  Out to 10 Years

Secondary Outcomes (2)

• 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

Interventions

M/L Taper with Kinectiv Technology Stems and Necks DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Orthopedic and Fracture Specialists

Portland, Oregon, 97225, United States

Location

MeSH Terms

Conditions

Hip Fractures; Hip Injuries

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Lynsey Boyle

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 19, 2019
• Study Start: January 22, 2020
• Primary Completion: November 5, 2024
• Study Completion: November 5, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)