MedPath

The Implant Removal Trial

Recruiting
Conditions
implant, removal, hardware, osteosynthesis, refracture, plates, nails, complicationsverwijderen osteosynthese, platen, pennen, refractuur, complicaties
Registration Number
NL-OMON27207
Lead Sponsor
fund = initiator = sponser
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
200
Inclusion Criteria

1. All patients of 18 years and older who have an osteosynthesis (plate or nail) of their clavicle, radius, ulna, femur or tibia and who are planned for an implant removal.

2. The fracture needs to be healed (consolidation) clinically and on radiology.

Exclusion Criteria

1. All patients younger than 18 years.

2. Patients who had an other trauma in their previous history of the same extremity, through which the already had a limitation of mobility, pain and/or stiffnes which could explain their complaints (when supposed that the complaints of the patient are possibily caused by the osteosynthesis material than the patient can be included for the trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Is the pre-operative suspected result of the operation being achieved?
Secondary Outcome Measures
NameTimeMethod
The incidence of the complications per- and post-operatively.
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