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出境医 / 临床实验 / MDR - PMCF Study for Taperloc Complete Stems

MDR - PMCF Study for Taperloc Complete Stems

Study Description
Brief Summary:
The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

Condition or disease Intervention/treatment
Hip Arthritis Hip Disease Hip Fractures Hip Injuries Hip Pain Chronic Device: Taperloc Complete Stem

Detailed Description:

The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and 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).

*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point

Study Design
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Study Type : Observational
Estimated Enrollment : 820 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems
Actual Study Start Date : February 13, 2020
Estimated Primary Completion Date : February 12, 2027
Estimated Study Completion Date : February 12, 2027
Arms and Interventions
Group/Cohort Intervention/treatment
Taperloc Complete Stems
Patients that have been implanted with a Taperloc Complete Stem to repair hip malfunction/disease.
Device: Taperloc Complete Stem
Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.

Outcome Measures
Primary Outcome Measures :
  1. 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 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.


Secondary Outcome Measures :
  1. Device Performance and Benefits evaluated through the Harris Hip Score [ Time Frame: Out to 10 Years ]
    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.

  2. Device Performance and Benefits evaluated through the Oxford Hip Score [ Time Frame: Out to 10 Years ]
    The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A consecutive series of patients implanted with the Taperloc Complete Stems in primary or revision total hip arthroplasty according to the approved indications.
Criteria

Inclusion Criteria:

  • Patient must be 18 years of age or older and skeletally mature
  • Patient must be willing and able to sign IRB approved informed consent
  • Patient must have undergone primary or revision hip arthroplasty with the -Taperloc Complete stem according to a cleared indication, which includes the following:
  • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • Correction of functional deformity
  • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques

Exclusion Criteria:

  • Off-label use
  • Infection
  • Sepsis
  • Osteomyelitis
  • Uncooperative patient or patient with neurologic disorders who are incapable of following directions
  • Osteoporosis
  • Metabolic disorders which may impair bone formation
  • Osteomalacia
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  • Vascular insufficiency, muscular atrophy, or neuromuscular disease
  • 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
Contacts and Locations

Contacts
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Contact: Richard Marek 574-453-7567 richard.marek@zimmerbiomet.com

Locations
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United States, Nevada
Orthopaedic Institute of Henderson Not yet recruiting
Henderson, Nevada, United States, 89052
Contact: Lisa DeBrouwer    702-565-6565 ext 218    lisa@oihnv.com   
Principal Investigator: Robert Tait, MD         
United States, Texas
Texas Health Physicians Group Recruiting
Plano, Texas, United States, 75243
Contact: Shuvie Dasgupta    972-981-7114    shuvalaxmidasgupta@texashealth.org   
Principal Investigator: Roger Emerson, MD         
United States, Washington
Proliance Orthopaedics and Sports Medicine Withdrawn
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold Zimmer Biomet
Tracking Information
First Submitted Date July 18, 2019
First Posted Date July 23, 2019
Last Update Posted Date December 17, 2020
Actual Study Start Date February 13, 2020
Estimated Primary Completion Date February 12, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 18, 2019)
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 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 18, 2019)
  • Device Performance and Benefits evaluated through the Harris Hip Score [ Time Frame: Out to 10 Years ]
    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.
  • Device Performance and Benefits evaluated through the Oxford Hip Score [ Time Frame: Out to 10 Years ]
    The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MDR - PMCF Study for Taperloc Complete Stems
Official Title Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems
Brief Summary The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and 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 Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and 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).

*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population A consecutive series of patients implanted with the Taperloc Complete Stems in primary or revision total hip arthroplasty according to the approved indications.
Condition
  • Hip Arthritis
  • Hip Disease
  • Hip Fractures
  • Hip Injuries
  • Hip Pain Chronic
Intervention Device: Taperloc Complete Stem
Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.
Study Groups/Cohorts Taperloc Complete Stems
Patients that have been implanted with a Taperloc Complete Stem to repair hip malfunction/disease.
Intervention: Device: Taperloc Complete Stem
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 18, 2019)
820
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 12, 2027
Estimated Primary Completion Date February 12, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient must be 18 years of age or older and skeletally mature
  • Patient must be willing and able to sign IRB approved informed consent
  • Patient must have undergone primary or revision hip arthroplasty with the -Taperloc Complete stem according to a cleared indication, which includes the following:
  • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • Correction of functional deformity
  • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques

Exclusion Criteria:

  • Off-label use
  • Infection
  • Sepsis
  • Osteomyelitis
  • Uncooperative patient or patient with neurologic disorders who are incapable of following directions
  • Osteoporosis
  • Metabolic disorders which may impair bone formation
  • Osteomalacia
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  • Vascular insufficiency, muscular atrophy, or neuromuscular disease
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Richard Marek 574-453-7567 richard.marek@zimmerbiomet.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04028687
Other Study ID Numbers MDRG2017-89MS-39H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor Zimmer Biomet
Collaborators Not Provided
Investigators
Study Director: Kacy Arnold Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date December 2020