Survival, ProsthesisNCT03510065
Prevision® PMCF Study
An observational study of Survival, Prosthesis, run by Aesculap AG at 1 site in Germany.
Trial summary
Monocentric, non-interventional Post-Market Clinical Follow-Up (PMCF) Study on past implantations of the Prevision® prosthesis; the survival rate of the Prevision® prosthesis shall be evaluated and compared to literature results on comparable Revision stems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Survival, Prosthesis
- What is being tested?
- Prevision®
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2016to 31 Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving a Prevision® stem between 2002 and 2012
Who may be able to join
- Patient received a Prevision® Hip Stem (curved or straight) between 2002 an 2012
- Patient gave his written consent for study participation
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Market Clinical Follow-Up Study Prevision®
Monocentric, non-interventional Post-Market Clinical Follow-Up (PMCF) Study on past implantations of the Prevision® prosthesis; the survival rate of the Prevision® prosthesis shall be evaluated and compared to literature results on comparable Revision stems.
- Conditions
- Survival, Prosthesis
- Being tested
- Prevision®
- Keywords
- hip arthroplasty, revision arthroplasty, survival
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevision®Device
One time Evaluation with documentation of one follow-up visit
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevision® survival
Kaplan Meier Survival Rate, retrospective Analysis of Patients operated between 2002 and 2012
Measured: 4-14 years after implantation
Secondary outcomes (8)
Clinical Results
Harris Hip Score: The score covers pain, function, absence of deformity, and range of motion. Pain is measured as pain severity and its effect on activities and need for pain medication.
Hip function score consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction.
There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).
Measured: 4-14 years after implantation
Ectopic Ossification
Radiological Results, Ectopic Ossification acc. to Brooker; retrospective Analysis of Patients operated between 2002 and 2012
Measured: 4-14 years after implantation
Sinking / Migration of the Stem
Radiological Results, Sinking / Migration of the Stem in [mm], Comparison to x-ray at Hospital discharge where available, retrospective Analysis of Patients operated between 2002 and 2012
Measured: 4-14 years after implantation
Radiological Evaluation of the Stem
Radiological Results of Radiolucent Lines, Osteolysis, Hypertrophy, Decrease of corticalis thickness, Cyst; retrospective Analysis of Patients operated between 2002 and 2012
Measured: 4-14 years after implantation
Quality of Life
Measured by EQ-5D-5L: The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: 4-14 years after implantation
Pain
Pain in the hip Joint, measured by Visual Analogue Scale: The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Measured: 4-14 years after implantation
Adverse Events
Documentation of any Adverse event
Measured: 4-14 years after implantation
Serious Adverse Events
Documentation of any Serious Adverse event
Measured: 4-14 years after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survival, ProsthesisStudies 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
- 150 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
- NCT03510065
- Sponsor's protocol ID
- AAG-O-H-1508
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 30 Apr 2018
- 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 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study Prevision®
- ClinicalTrials.gov ID
- NCT03510065
- Acronym / sponsor ID
- AAG-O-H-1508
- Conditions
- Survival, Prosthesis
- Keywords
- hip arthroplasty, revision arthroplasty, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 27 Apr 2018 (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.
Monocentric, non-interventional Post-Market Clinical Follow-Up (PMCF) Study on past implantations of the Prevision® prosthesis; the survival rate of the Prevision® prosthesis shall be evaluated and compared to literature results on comparable Revision stems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving a Prevision® stem between 2002 and 2012
Key inclusion criteria (2 listed)
- Patient received a Prevision® Hip Stem (curved or straight) between 2002 an 2012
- Patient gave his written consent for study participation
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Prevision®One time Evaluation with documentation of one follow-up visit | Device | – |
Primary outcome
Prevision® survival
Time frame: 4-14 years after implantation
Kaplan Meier Survival Rate, retrospective Analysis of Patients operated between 2002 and 2012
8 secondary outcomes
Clinical Results
Time frame: 4-14 years after implantation
Ectopic Ossification
Time frame: 4-14 years after implantation
Sinking / Migration of the Stem
Time frame: 4-14 years after implantation
Radiological Evaluation of the Stem
Time frame: 4-14 years after implantation
Quality of Life
Time frame: 4-14 years after implantation
Pain
Time frame: 4-14 years after implantation
Adverse Events
Time frame: 4-14 years after implantation
Serious Adverse Events
Time frame: 4-14 years after implantation
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 30 Apr 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survival, Prosthesis, run by Aesculap AG at 1 site 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 2 inclusion and 1 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 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prevision® survival (time frame: 4-14 years after implantation). 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 30 Apr 2018.