OsteolysisNCT04255966
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
An observational study of Osteolysis and Arthroplasty Complications, run by Aesculap AG at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint
- What is being tested?
- Plasmafit® Revision Structan®
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 4 sitesGermany
- Study dates
- 12 Apr 2021to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Gemeinschaftskrankenhaus Bonn
Bonn, North Rhine-Westphalia, 53113
Herzogin Elisabeth Hospital
Braunschweig, Niedersachse, 38124
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421
Orthopädische Klinik König-Ludwig-Haus
Würzburg, Bavaria, 97074
About this study
Official title: 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
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.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis, Rheumatic Arthritis, Fractures, Hip
- Being tested
- Plasmafit® Revision Structan®
- Keywords
- Revision of the acetabular implant, orthopaedic surgery, osteolysis, wear particles, cup loosening, malpositioned cup
- Medical subject headings
- Osteolysis, Joint Diseases, Rheumatic Fever, Hip Fractures, Femur Head Necrosis, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmafit® Revision Structan®Device
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
| Study group | Role | What they receive |
|---|---|---|
| Plasmafit® Revision Structan® | Plasmafit® Revision Structan® Hip Endoprosthesis Cup Receives: Device: Plasmafit® Revision Structan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to five years postoperatively
Secondary outcomes (8)
Survival of the implant
Any removal or exchange of the acetabular cup or the polyethylene inlay is defined as revision.
A removal of the stem is not evaluated as acetabular revision but will be documented and evaluated as part of postoperative complications.
The revision-free survival will be assessed using the Kaplan-Meier method.
Measured: up to five years postoperatively
Quality of Life over time
EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of three responses reflecting severity (no problems/some or moderate problems/extreme problems).
Measured: up to five years postoperatively
Radiological Assessment: Osseointegration of the cup over time
The acetabular component in AP view is divided into the three regions I-III as defined by DeLee-Charnley. All three regions will be assessed for osteolysis the implant, to allow an estimation of the osseous integration and stability of the implant.
Measured: at 3 months, 24 months, 5 years follow-up
Radiological assessment: Radiographic loosening of the cup over time
The acetabular component in AP view is divided into the three regions I-III as defined by DeLee-Charnley. All three regions will be assessed for and radiolucent lines around the implant, to allow an estimation of the osseous integration and stability of the implant.
Measured: at 3 months, 24 months, 5 years follow-up
Technical problems during surgery
Technical problems with instruments, implants or containers, instrument related issues
Measured: Intraoperative
Impingement
The incidence of impingement during intraoperative mobilization is documented;
Measured: Intraoperative
General handling of instruments / containers
Complaints or problems with the handling of instruments, implants or containers, instrument related issues
Measured: Intraoperative
Complications
All complications in the postoperative course are recorded
Measured: up to 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start12 Apr 2021
- Primary completion16 Aug 2023
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Landgraeber, Prof. Dr., Principal investigator, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255966
- Sponsor's protocol ID
- AAG-O-H-1821
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04255966
- Acronym / sponsor ID
- AAG-O-H-1821
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis, Rheumatic Arthritis, Fractures, Hip
- Keywords
- Revision of the acetabular implant, orthopaedic surgery, osteolysis, wear particles, cup loosening, malpositioned cup
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasmafit® Revision Structan® | – | Device: Plasmafit® Revision Structan®Plasmafit® Revision Structan® Hip Endoprosthesis Cup |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmafit® Revision Structan®Plasmafit® Revision Structan® Hip Endoprosthesis Cup | Device | Plasmafit® Revision Structan® |
Primary outcome
Harris Hip Score (Functional results of the operated hip) over time
Time frame: up to five years postoperatively
The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time
8 secondary outcomes
Survival of the implant
Time frame: up to five years postoperatively
Quality of Life over time
Time frame: up to five years postoperatively
Radiological Assessment: Osseointegration of the cup over time
Time frame: at 3 months, 24 months, 5 years follow-up
Radiological assessment: Radiographic loosening of the cup over time
Time frame: at 3 months, 24 months, 5 years follow-up
Technical problems during surgery
Time frame: Intraoperative
Impingement
Time frame: Intraoperative
General handling of instruments / containers
Time frame: Intraoperative
Complications
Time frame: up to 5 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Landgraeber, Prof. Dr. principal investigator
University Hospital, Saarland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteolysis and Arthroplasty Complications, run by Aesculap AG at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (Functional results of the operated hip) over time (time frame: up to five years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.