Anterior Knee Pain After Tibial Nailing

April 19, 2010 updated by: University of Zagreb

Nail Position Has an Influence on Anterior Knee Pain After Tibial Intramedullary Nailing

Anterior knee pain (AKP) is a common complication following intramedullary (IM) nailing of a tibial shaft fracture. The purpose of this prospective study was to determine if there is an association between AKP and nail position. The investigators have analyzed postoperative outcome results and the possible relationship between AKP according to the visual-analog scale (VAS) scale, and nail position marked as a distance from the tip of the nail to the tibial plateau (NP) and tuberositas tibiae (NT), measured postoperatively on L-L knee X-rays.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to determine the possible relationship between anterior knee pain (AKP) and nail position marked as a distance from tip of nail to tibial plateau (NP) and to the tuberositas tibiae (NT).

We evaluated postoperative outcome results of 50 patients in the last 3 years with healed fractures initially treated with intramedullary (IM) reamed nails with 2 or 3 interlocking screws on both parts of the nail and with the use of medial peritendinous incision for nail entry portal. Patients marked a point on the visual analog scale (VAS) that corresponded to the level of postoperative AKP felt. Two groups of patients were formed on the basis of AKP (pain level was neglected): groups A and B, with and without pain, respectively.

We found that the difference between the two groups concerning NP measurements was statistically significant, but not concerning NT measurements (P < 0.05). Patients were classified by pain with high accuracy (98%) according to a classification tree.

We conclude that the symptoms of AKP did not appear if the tip of the nail position was more than 6.0 mm from the NP and more than 2.6 mm from the NT. However, for better evaluation of these results it will be necessary to examine more postoperative patients with AKP.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • University of Zagreb School of Medicine, Department of Traumatology

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population consists of primary care hospital trauma patients with tibial shaft fractures treated with intramedullary nailing.

Description

Inclusion Criteria:

  • tibial shaft fractures
  • fracture treatment with intramedullary nailing with 2 or 3 interlocking screws on both ends of the nail

Exclusion Criteria:

  • amputated legs

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: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tibial shaft fractures
Patients had tibial shaft fractures in the last 3 years. All were treated with intramedullary (IM) reamed nails with 2 or 3 interlocking screws.
Procedure: Tibial intramedullary nailing
Patients' operations were performed using the peritendinous approach. A medial longitudinal incision was made, with care being taken not to damage the patellar tendon or its sheath. Standard proximal and distal locking screws were used. All patients were given postoperative instructions for thigh muscle rehabilitation and the same physiotherapy was performed after IM nailing during hospitalization. Nails were removed from some of the patients with the presence of knee pain or pain at the insertion points of the locking screws, however, no nails were removed earlier than one year postoperatively. Proof of the healed bone fracture was confirmed by radiologic examination.
Other Names:
  • tibial fractures
  • intramedullary nailing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior knee pain
Time Frame: 1 year
Anterior knee pain was assessed postoperatively with the visual analog scale (VAS). Patients generally had pain when kneeling, at the insertion point of surgical screws, or at the back of knee upon flexing.
1 year

Collaborators and Investigators

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

Sponsor

University of Zagreb

Investigators

  • Principal Investigator: Nikica Darabos, MD, PhD, University of Zagreb School of Medicine

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

January 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

April 20, 2010

Last Update Submitted That Met QC Criteria

April 19, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AKP

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.

Clinical Trials on Knee Pain

Clinical Trials on Tibial intramedullary nailing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe