NCT03164408

Brief 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 implant removal.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,545

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

May 21, 2017

Last Update Submit

May 21, 2017

Conditions

Implant ComplicationComplication, PostoperativeImplant Site Infection

Outcome Measures

Primary Outcomes (1)

  • Complications after implant Removal

    4 weeks postoperatively

Interventions

Orthopaedic Implant RemovalPROCEDURE

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Elective aseptic orthopaedic Implant removal

You may not qualify if:

  • Arthroplasty present infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arnold J Suda, MD, PhD

    University Medical Center Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant Orthopaedic and Trauma Surgeon

Study Record Dates

First Submitted

May 21, 2017

First Posted

May 23, 2017

Study Start

January 1, 2014

Primary Completion

December 31, 2015

Study Completion

April 5, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share