Total Hip ArthroplastyNCT02019849
Post Market Clinical Follow-Up of Plasmafit® Cup
An observational study of Total Hip Arthroplasty, run by Aesculap AG at 2 sites in Germany.
Trial summary
Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Plasmafit® Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- 18 Jun 2012to 27 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Specialist Clinical Centre
Who may be able to join
- Minimum age 18 years
- Indication for cementless total hip arthroplasty
- Patient consent for study participation
- Physical and mental willingness to participate at clinical and radiological follow-up
Who cannot join
- Patient not available for follow-up
- Increased anesthetics risks according to the "American Society of Anesthesiology": ASA IV
- Tumor
- Alcohol or drug abuse
- Permanent cortisone therapy
- Clinically relevant infection
Show all 10Show fewer
- Pregnancy or planned pregnancy
- Prior interventions like osteotomy, fracture treatment or prior THA at the concerned hip
- Acute fracture at the concerned hip
- Patients needing a cemented hip arthroplasty
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Vulpius-Klinik Bad Rappenau
Bad Rappenau
Diakonie-Klinikum Stuttgart
Stuttgart
About this study
Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Plasmafit® Total Hip Arthroplasty
- Keywords
- THA, Plasmafit®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmafit® Total Hip ArthroplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| Plasmafit® Total Hip Arthroplasty | Not described Receives: Device: Plasmafit® Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival Rates
Implant survival is analysed at follow-up examinations at 3 months, 12 months, 5 years and 10 years
Measured: 10 years
Secondary outcomes (5)
Osteolysis
Radiological Outcome
Measured: 3 months, 12 months, 5 years, 10 years
Ossifications
Radiological Outcome
Measured: 3 months, 12 months, 5 years, 10 years
Implant Position
Radiological Outcome
Measured: 3 months, 12 months, 5 years, 10 years
Migration of Plasmafit®
Radiological Outcome
Measured: 3 months, 12 months, 5 years, 10 years
Clinical Outcome
Harris Hip Score
Measured: 3 months, 12 months, 5 years, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study start18 Jun 2012
- Primary completion4 Oct 2012
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019849
- Sponsor's protocol ID
- AAG-O-H-1213
- Status last verified
- Nov 2025
- First submitted
- 4 Dec 2013
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up of Plasmafit® Cup
- ClinicalTrials.gov ID
- NCT02019849
- Acronym / sponsor ID
- AAG-O-H-1213
- Conditions
- Total Hip Arthroplasty
- Keywords
- THA, Plasmafit®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2012 (actual)
- Primary completion
- 4 Oct 2012 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 24 Dec 2013 (estimated)
- 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.
Twelve months follow-up of implant survival and clinical and radiological follow-up of Plasmafit® Cup.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasmafit® Total Hip Arthroplasty | – | Device: Plasmafit® Total Hip Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Specialist Clinical Centre
Key inclusion criteria (4 listed)
- Minimum age 18 years
- Indication for cementless total hip arthroplasty
- Patient consent for study participation
- Physical and mental willingness to participate at clinical and radiological follow-up
Key exclusion criteria (10 listed)
- Patient not available for follow-up
- Increased anesthetics risks according to the "American Society of Anesthesiology": ASA IV
- Tumor
- Alcohol or drug abuse
- Permanent cortisone therapy
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® Total Hip Arthroplasty | Device | Plasmafit® Total Hip Arthroplasty |
Primary outcome
Implant Survival Rates
Time frame: 10 years
Implant survival is analysed at follow-up examinations at 3 months, 12 months, 5 years and 10 years
5 secondary outcomes
Osteolysis
Time frame: 3 months, 12 months, 5 years, 10 years
Ossifications
Time frame: 3 months, 12 months, 5 years, 10 years
Implant Position
Time frame: 3 months, 12 months, 5 years, 10 years
Migration of Plasmafit®
Time frame: 3 months, 12 months, 5 years, 10 years
Clinical Outcome
Time frame: 3 months, 12 months, 5 years, 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty, run by Aesculap AG at 2 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Implant Survival Rates (time frame: 10 years). 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 17 Nov 2025.