Condition or disease | Intervention/treatment |
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Hip Arthritis Hip Disease Hip Fractures Hip Injuries Hip Pain Chronic | Device: Taperloc Complete Stem |
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 |
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 |
Group/Cohort | Intervention/treatment |
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Taperloc Complete Stems
Patients that have been implanted with a Taperloc Complete Stem to repair hip malfunction/disease.
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Device: Taperloc Complete Stem
Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard Marek | 574-453-7567 | richard.marek@zimmerbiomet.com |
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 |
Study Director: | Kacy Arnold | Zimmer Biomet |
Tracking Information | |||||||
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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 |
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.
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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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 |
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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 |
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Intervention | Device: Taperloc Complete Stem
Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.
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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
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Recruiting | ||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts |
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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 |
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IPD Sharing Statement |
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Responsible Party | Zimmer Biomet | ||||||
Study Sponsor | Zimmer Biomet | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Zimmer Biomet | ||||||
Verification Date | December 2020 |