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Anterior Knee Pain After Tibial Nailing

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. Identifier: NCT01106963
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : April 20, 2010
Information provided by:
University of Zagreb

Brief Summary:
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.

Condition or disease Intervention/treatment
Knee Pain Procedure: Tibial intramedullary nailing

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nail Position Has an Influence on Anterior Knee Pain After Tibial Intramedullary Nailing
Study Start Date : January 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The population consists of primary care hospital trauma patients with tibial shaft fractures treated with intramedullary nailing.

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

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 identifier (NCT number): NCT01106963

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University of Zagreb School of Medicine, Department of Traumatology
Zagreb, Croatia, 10000
Sponsors and Collaborators
University of Zagreb
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Principal Investigator: Nikica Darabos, MD, PhD University of Zagreb School of Medicine
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Responsible Party: General Hospital Varazdin, National Health Insurance Identifier: NCT01106963    
Other Study ID Numbers: AKP
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: April 20, 2010
Last Verified: April 2010
Keywords provided by University of Zagreb:
tibial fractures
intramedullary nailing