Tibial Fractures Clinical Trial
Official title:
Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial
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
After surgery with standard intramedullary nailing technique in tibia fractures, 40-80% of
the patients still complain of anterior knee pain postoperative. The expected advantages of
the semi-extended nailing technique is less anterior knee pain and less malunion of the
fracture.
Using the semi-extended nailing technique also might give the advantage of better position
of the nail by a more concentric reaming of the tibia, due to less tension on the patella
tendon during reaming process.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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