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CompletedNCT01106963Updated Apr 20, 2010

Anterior Knee Pain After Tibial Nailing

An observational study in Knee Pain, sponsored by University of Zagreb. Completed at 1 site in Croatia. Per ClinicalTrials.gov, last updated 2010-04-20.

Sponsored by University of Zagreb · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Knee Pain

Keywords

  • knee
  • tibial fractures
  • pain
  • osteosynthesis
  • intramedullary nailing
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In context

Lead sponsor

University of Zagreb is the lead sponsor of 67 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • amputated legs
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)

Groups and cohorts

  • 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

Interventions

  • ProcedureTibial 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.

    Also known as: tibial fractures, intramedullary nailing

06

What researchers measure

Primary outcomes

  1. Anterior knee pain

    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.

    Time frame: 1 year

07

Study locations

1 site
  • University of Zagreb School of Medicine, Department of Traumatology
    Zagreb, 10000, Croatia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01106963
Lead sponsor
University of Zagreb
First posted
Apr 20, 2010
Start date
Jan 2006
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Apr 20, 2010

Study contacts

Nikica Darabos, MD, PhD
principal investigator · University of Zagreb School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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