Trials / Recruiting
RecruitingNCT04028687
MDR - PMCF Study for Taperloc Complete Stems
Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 820 (estimated)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Taperloc Complete Stem | Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease. |
Timeline
- Start date
- 2020-02-13
- Primary completion
- 2032-02-12
- Completion
- 2032-02-12
- First posted
- 2019-07-23
- Last updated
- 2025-03-11
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04028687. Inclusion in this directory is not an endorsement.