Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04027140
Other study ID # MDRG2017-89MS-56H
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 22, 2020
Est. completion date September 2024

Study information

Verified date December 2023
Source Zimmer Biomet
Contact Abigail Fishel
Phone 5745261765
Email abigail.fishel@zimmerbiomet.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 164
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Orthopedic and Fracture Specialists Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 Device Performance and Benefits evaluated through the Harris Hip Score outcome measure. The HHS is divided into 4 sub-categories; pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). Patients select a discrete set of answers which correspond to predefined point allocations based on the category. To obtain a final score, these values are summed. Out to 10 Years
Secondary Device Performance and Benefits evaluated through the EuroQolo Five Dimensions Questionnaire (EQ5D) outcome measure. The EQ-5D measures 5 dimensions of general health; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a total of 5 questions. It is accompanied by the patient's self-assessment with the VAS. There are three versions of the EQ-5D; 3 level (3L), 5 level (5L), and a youth (Y) version based off of the 3L model.
Each dimension is assigned one of three discrete levels for evaluation on the day of administration for the three level evaluation:
Level 1 - No problems, no disability Level 2 - Some problems, moderate disability Level 3 - A lot of problems, severe disability
The final score is a five digit composite of the responses ranging between 33333 - 11111 with 243 possible combinations in between for the 3L test. The 5L test can measure 3,125 different health states and ranges between 55555-11111.
Out to 10 Years
See also
  Status Clinical Trial Phase
Completed NCT02507609 - Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium N/A
Completed NCT03906864 - Care Pathway for Sub-acute Hip Rehabilitation N/A
Recruiting NCT04063891 - Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients N/A
Completed NCT05039879 - Life Improving Factors After a Hip Fracture
Not yet recruiting NCT03887494 - Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY) N/A
Terminated NCT03065101 - Trigen InterTAN vs Sliding Hip Screw RCT N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Completed NCT03545347 - Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture. Phase 2
Recruiting NCT05971173 - Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery Early Phase 1
Active, not recruiting NCT04957251 - Anterior vs Posterior Approach for Hip Hemiarthroplasty N/A
Terminated NCT04372966 - Uncemented Versus Cemented Total Hip Arthroplasty for Displaced Intracapsular Hip Fractures N/A
Withdrawn NCT05030688 - Fascia Iliaca Compartment Block and PENG Block for Hip Arthroplasty N/A
Completed NCT04424186 - 'Rehabilitation for Life' N/A
Not yet recruiting NCT04183075 - Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture N/A
Withdrawn NCT05518279 - Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures Phase 3
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Active, not recruiting NCT02247791 - Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty N/A
Completed NCT00746876 - Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. N/A
Completed NCT00058864 - The HIP Impact Protection Program (HIP PRO) N/A