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Knee Pain After Intramedullary Nailing in the Tibia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649360
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Nikolaj Erin-Madsen, Copenhagen University Hospital, Hvidovre

Study Description
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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.

Condition or disease
Tibia Fracture Knee Pain Chronic

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.

Study Design
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Study Type : Observational
Actual Enrollment : 223 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Knee Pain After Tibial Shaft Fracture Treated With Intramedullary Nailing
Actual Study Start Date : November 1, 2009
Actual Primary Completion Date : October 31, 2014
Actual Study Completion Date : December 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Knee Pain after Tibial Shaft Fracture Treated with Intramedullary Nailing [ Time Frame: 1st of November 2009 till 30th of October 2014. ]
    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. We used the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire to collect patient data. It is used to assess patient's subjective opinion about symptoms related to the knee and other associated problems. The questionnaire has been translated and validated in Danish and consists of 5 subscales: pain, symptoms, function in daily living (ADL) function in sports and recreation and knee-related QOL. Each subscale has between 4 and 17 questions (a total of 42 questions) with each question having 5 options ranging from no symptoms to severe symptoms. Each question gets a score from 0-4 and a score from 0-100 is calculated. 100 indicating no symptoms and 0 indicates major symptoms.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649360


Locations
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Denmark
Copenhagen University Hospital of Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Investigators
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Study Director: Nikolaj Erin-Madsen, MD Copenhagen University Hospital of Hvidovre
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nikolaj Erin-Madsen, Principal Investigator, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT03649360    
Other Study ID Numbers: IMN Study
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan of sharing data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nikolaj Erin-Madsen, Copenhagen University Hospital, Hvidovre:
Knee pain
Intramedullary tibial nail
KOOS
Additional relevant MeSH terms:
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Tibial Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries