Status:
TERMINATED
MDR - M/L Taper With Kinectiv Technology Stems and Necks
Lead Sponsor:
Zimmer Biomet
Conditions:
Hip Disease
Hip Fractures
Eligibility:
All Genders
18+ years
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 prim...
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 prim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 5 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04027140
Start Date
January 22 2020
End Date
November 5 2024
Last Update
December 31 2024
Active Locations (1)
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1
Orthopedic and Fracture Specialists
Portland, Oregon, United States, 97225