MDR - M/L Taper With Kinectiv Technology Stems and Necks
TerminatedNCT04027140
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Hip Disease
- Hip Fractures
- Hip Injuries
- Hip Arthritis
- Hip Pain Chronic
- Interventions
- Device: M/L Taper with Kinectiv Technology Stems and Necks
- Sponsor
- Zimmer Biomet
- Start date
- 2020-01-22
- Primary completion
- 2024-11-05
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04027140