Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
Study NCT ID:
NCT04122157
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2019-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem
Sponsor:
Smith & Nephew Orthopaedics AG
Organization:
Study Overview
Official Title:
Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SL-PLUS MIA
Brief Summary:
Summary from initial protocol
Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study
Study design: prospective, single-center, observational, non-comparative study
Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)
Intervention (if applicable): Implantation of a total hip endoprosthesis
Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration; clinical: Harris Hip Score, implant-related complications, revisions; patient questionnaire (WOMAC)
Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.
Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study
Study design: prospective, single-center, observational, non-comparative study
Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)
Intervention (if applicable): Implantation of a total hip endoprosthesis
Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration; clinical: Harris Hip Score, implant-related complications, revisions; patient questionnaire (WOMAC)
Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: