NCT01106963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
Last Updated

April 20, 2010

Status Verified

April 1, 2010

Enrollment Period

3.9 years

First QC Date

April 14, 2010

Last Update Submit

April 19, 2010

Conditions

Keywords

kneetibial fracturespainosteosynthesisintramedullary nailing

Outcome Measures

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.

    1 year

Study Arms (1)

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

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
Tibial shaft fractures

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • amputated legs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zagreb School of Medicine, Department of Traumatology

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Tibial FracturesPain

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fracture Fixation, InternalFracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Nikica Darabos, MD, PhD

    University of Zagreb School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2010

First Posted

April 20, 2010

Study Start

January 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 20, 2010

Record last verified: 2010-04

Locations