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Completed

NCT Number: NCT01106963

Anterior Knee Pain After Tibial 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Zagreb School of Medicine, Department of Traumatology

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tibial intramedullary nailing

Procedure

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 20, 2010
Registry last updated
Apr 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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