Orthopaedic Implant Removal

May 21, 2017 updated by: Arnold J Suda, MD, PhD, Universitätsmedizin Mannheim

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

1545

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all patients in between scheduled period of time ( 2 years)

Description

Inclusion Criteria:

Elective aseptic orthopaedic Implant removal

Exclusion Criteria:

Arthroplasty present infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complications after implant Removal
Time Frame: 4 weeks postoperatively
4 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arnold J Suda, MD, PhD, University Medical Center Mannheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

April 5, 2017

Study Registration Dates

First Submitted

May 21, 2017

First Submitted That Met QC Criteria

May 21, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 21, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/01SUA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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