Implant ComplicationNCT03164408
Orthopaedic Implant Removal
An observational study of Implant Complication and Complication, Postoperative, run by Universitätsmedizin Mannheim.
Trial summary
The necessity of orthopedic implant removal is under intense discussion and even if it is performed as an elective procedure, the risk of complications is present. Aim of the study is to identify parameters responsible for an increased risk of early post-operative complications after elective aseptic orthopedic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Implant Complication, Complication, Postoperative, Implant Site Infection
- What is being tested?
- Orthopaedic Implant Removal
- Type of treatment
- Surgery or procedure
- How many people
- 1,545 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 5 Apr 2017
- 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
- Child, Adult, Older adult
Study population: all patients in between scheduled period of time ( 2 years)
Who may be able to join
- Elective aseptic orthopaedic Implant removal
Who cannot join
- Arthroplasty present infection
About this study
Official title: High Early Post-operative Complication Rate After Elective Aseptic Orthopedic Implant Removal of Upper and Lower Limb
The necessity of orthopedic implant removal is under intense discussion and even if it is performed as an elective procedure, the risk of complications is present.
Aim of the study is to identify parameters responsible for an increased risk of early post-operative complications after elective aseptic orthopedic implant removal.
- Being tested
- Orthopaedic Implant Removal
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopaedic Implant RemovalProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications after implant Removal
Measured: 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Jan 2014
- Primary completion31 Dec 2015
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies 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
- Retrospective
- Enrolment
- 1,545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnold J Suda, MD, PhD, Universitätsmedizin Mannheim
- Investigators
- Arnold J Suda, MD, PhD, Principal investigator, University Medical Center Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164408
- Sponsor's protocol ID
- 2017/01SUA
- Status last verified
- May 2017
- First submitted
- 21 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Early Post-operative Complication Rate After Elective Aseptic Orthopedic Implant Removal of Upper and Lower Limb
- ClinicalTrials.gov ID
- NCT03164408
- Acronym / sponsor ID
- 2017/01SUA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,545 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 23 May 2017 (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 necessity of orthopedic implant removal is under intense discussion and even if it is performed as an elective procedure, the risk of complications is present.
Aim of the study is to identify parameters responsible for an increased risk of early post-operative complications after elective aseptic orthopedic implant removal.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patients in between scheduled period of time ( 2 years)
Key inclusion criteria (1 listed)
- Elective aseptic orthopaedic Implant removal
Key exclusion criteria (1 listed)
- Arthroplasty present infection
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 |
|---|---|---|
| Orthopaedic Implant Removal | Procedure or surgery | – |
Primary outcome
Complications after implant Removal
Time frame: 4 weeks postoperatively
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 23 May 2017.
- Individual participant dataSharing planned: No
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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.
Arnold J Suda, MD, PhD principal investigator
University Medical Center Mannheim
Questions about this trial
What is this clinical trial studying?
An observational study of Implant Complication and Complication, Postoperative, run by Universitätsmedizin Mannheim.
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 1 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Complications after implant Removal (time frame: 4 weeks 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 23 May 2017.