Hip DiseaseNCT04027140
MDR - M/L Taper With Kinectiv Technology Stems and Necks
An observational study of Hip Disease and Hip Fractures, run by Zimmer Biomet at 1 site in United States.
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*. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Disease, Hip Fractures, Hip Injuries
- What is being tested?
- M/L Taper with Kinectiv Technology Stems and Necks
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2020to 5 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patient must be 18 years of age or older
- Rheumatoid arthritis
- Osteoarthritis
- Traumatic arthritis
- Polyarthritis
- Collagen disorders
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic and Fracture Specialists
Portland, Oregon, 97225
About this study
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
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.
Read the 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.
- Conditions
- Hip Disease, Hip Fractures, Hip Injuries, Hip Arthritis, Hip Pain Chronic
- Being tested
- M/L Taper with Kinectiv Technology Stems and Necks
- Medical subject headings
- Hip Fractures, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M/L Taper with Kinectiv Technology Stems and NecksDevice
Patients that have been implanted with a M/L Taper with Kinectiv Technology Stem and/or neck to repair hip malfunction/disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Out to 10 Years
Secondary outcomes (2)
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.
Measured: Out to 10 Years
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.
Measured: Out to 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start22 Jan 2020
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Why it stopped: Zimmer Biomet no longer intends to market the M/L Taper with Kinectiv in the European Union and therefore has terminated study MDRG2017-89MS-56H.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DiseaseStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynsey Boyle, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027140
- Sponsor's protocol ID
- MDRG2017-89MS-56H
- Status last verified
- Dec 2024
- First submitted
- 18 Jul 2019
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04027140
- Acronym / sponsor ID
- MDRG2017-89MS-56H
- Conditions
- Hip Disease, Hip Fractures, Hip Injuries, Hip Arthritis, Hip Pain Chronic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Zimmer Biomet no longer intends to market the M/L Taper with Kinectiv in the European Union and therefore has terminated study MDRG2017-89MS-56H.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (13 listed)
- Patient must be 18 years of age or older
- Rheumatoid arthritis
- Osteoarthritis
- Traumatic arthritis
- Polyarthritis
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M/L Taper with Kinectiv Technology Stems and NecksPatients that have been implanted with a M/L Taper with Kinectiv Technology Stem and/or neck to repair hip malfunction/disease. | Device | – |
Primary outcome
Device safety assessed through the frequency and incidence of revisions, complications and adverse events
Time frame: Out to 10 Years.
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.
Device safety assessed through radiographic assessments
Time frame: Out to 10 Years
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.
2 secondary outcomes
Device Performance and Benefits evaluated through the Harris Hip Score outcome measure.
Time frame: Out to 10 Years
Device Performance and Benefits evaluated through the EuroQolo Five Dimensions Questionnaire (EQ5D) outcome measure.
Time frame: Out to 10 Years
Results and safety
The study was stopped early (reason given: Zimmer Biomet no longer intends to market the M/L Taper with Kinectiv in the European Union and therefore has terminated study MDRG2017-89MS-56H.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynsey Boyle study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Disease and Hip Fractures, run by Zimmer Biomet at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Zimmer Biomet no longer intends to market the M/L Taper with Kinectiv in the European Union and therefore has terminated study MDRG2017-89MS-56H.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device safety assessed through the frequency and incidence of revisions, complications and adverse events (time frame: Out to 10 Years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.