Clinical trial NCT03649360: Knee Pain After Intramedullary Nailing in the Tibia
Official title: Knee Pain After Tibial Shaft Fracture Treated With Intramedullary Nailing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibia Fracture
Knee Pain Chronic
Keywords: Knee pain
Intramedullary tibial nail
KOOS
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent surgery with reamed, locked intramedullary nailing after isolated tibial shaft fracture at one of the above mentioned orthopedic departments between 1st of November 2009 and 30th of October 2014 were sought.

Brief summary: The primary objective of this study is to evaluate the long-term outcome after inserting an intramedullary nail in patients with a tibial shaft fracture using an injury-specific questionnaire.

Detailed description: Introduction

The treatment of choice for unstable diaphyseal fractures in the tibia is reamed insertion of an intramedullary nail (IMN) with the additional placement of interlocking screws. The most common complication after insertion of an IMN as treatment of tibial shaft fractures is chronic knee pain with reported rates between 10 % and 87 % with a mean of 47,4 % in metaanalyses.

Methods

The primary objective of this study is to evaluate the long-term outcome after inserting an IMN in patients with a tibial shaft fracture using an injury-specific questionnaire.

This study includes patients operated on five Danish hospitals. A database search was made using operational codes for insertion of an IMN in a five-year period. Patients aged 18 years or older, alive and residing in Denmark at the time of follow-up could be included in the study. These patients then received a Knee Injury and Osteoarthritis Score (KOOS) questionnaire by mail with questions regarding knee-specific symptoms, stiffness, pain, function and quality of life. Questionnaires were filled out and returned to the corresponding physician for further analyze. Patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older, alive and residing in Denmark at the time of follow-up could be included in the study.

Exclusion Criteria:

* Patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.

Primary outcomes:
measure: Knee Pain after Tibial Shaft Fracture Treated with Intramedullary Nailing
timeFrame: 1st of November 2009 till 30th of October 2014.
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Copenhagen University Hospital of Hvidovre
Study officials:
affiliation: Copenhagen University Hospital of Hvidovre
name: Nikolaj Erin-Madsen, MD
role: STUDY_DIRECTOR
References:
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