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Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails

NCT01358292 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2016-06-17

No results posted yet for this study

Summary

Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\& Nephew's Trigen META intramedullary nailing system; comparing two surgical techniques: Group A=standard technique(90º of knee flexion) and Group B=with the semi-extended surgical technique. (2\*100 patients)

Research Objectives:

The primary research objectives are to evaluate:

i) anterior knee pain and ii) the nail position and overall fracture alignment

Outcome Measures:

1. Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.
2. Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires
3. Knee-related adverse events
4. Overall fracture alignment

Conditions

  • Tibial Fractures

Interventions

PROCEDURE

Semi-extended Surgical Technique

Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.

PROCEDURE

Standard Surgical Technique

Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.

Sponsors & Collaborators

  • Smith & Nephew Orthopaedics AG

    lead INDUSTRY

Principal Investigators

  • Alan Johnstone, Professor · Aberdeen Royal Infirmary

  • Pedro Caba, Dr. · Hospital de 12 Octubre, Madrid

  • Markus Graf, Dr. · Medizinisches Zentrum StädteRegion Aachen

  • Ismael Escriba, Dr. · HOSPITAL LA FE VALENCIA

  • Daren Forward, MA, FRCS, DM · Nottingham University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-09-30
Completion
2015-10-31

Countries

  • Germany
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01358292 on ClinicalTrials.gov