Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Prospective, Multi-centric, Comparative, Long-term Clinical Follow-Up Study for the Evidence of Safety and Performance Indicators of the Plasmafit® Revision Structan® Hip Endoprosthesis Cup
1 other identifier
observational
60
1 country
4
Brief Summary
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2021
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
ExpectedMay 6, 2026
April 1, 2026
2.3 years
January 30, 2020
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Harris Hip Score (Functional results of the operated hip) over time
The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time
up to five years postoperatively
Secondary Outcomes (8)
Survival of the implant
up to five years postoperatively
Quality of Life over time
up to five years postoperatively
Radiological Assessment: Osseointegration of the cup over time
at 3 months, 24 months, 5 years follow-up
Radiological assessment: Radiographic loosening of the cup over time
at 3 months, 24 months, 5 years follow-up
Technical problems during surgery
Intraoperative
- +3 more secondary outcomes
Study Arms (1)
Plasmafit® Revision Structan®
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Interventions
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Eligibility Criteria
Patients having acute disorders of the hip, requiring primary or revision surgery, which cannot be treated by other therapies: * Degenerative osteoarthritis * Rheumatic arthritis * Fractures of the joint * Femoral head necrosis * Revision surgery where a sufficient intraoperative press-fit can be achieved
You may qualify if:
- Indication for the cementless Plasmafit® Revision Structan® Hip Endoprosthesis Cup (primary and revision cases, with bone conditions typically demanding a press-fit revision cup)
- Written informed consent
- Cases where a press-fit cup fixation is possible
You may not qualify if:
- Patients \< 18 years
- Pregnant patients
- Patients not able to comply with the study demands, i.e. follow-up visits (mentally or physically)
- Patient has an infection in the hip joint region
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aesculap AGlead
Study Sites (4)
Orthopädische Klinik König-Ludwig-Haus
Würzburg, Bavaria, 97074, Germany
Herzogin Elisabeth Hospital
Braunschweig, Niedersachse, 38124, Germany
Gemeinschaftskrankenhaus Bonn
Bonn, North Rhine-Westphalia, 53113, Germany
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Landgraeber, Prof. Dr.
University Hospital, Saarland
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2020
First Posted
February 5, 2020
Study Start
April 12, 2021
Primary Completion
August 16, 2023
Study Completion (Estimated)
June 1, 2027
Last Updated
May 6, 2026
Record last verified: 2026-04