Clinical trial NCT01358292: Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails
Official title: Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tibial Fractures
Keywords: Intramedullary tibia nailing
Anterior Knee Pain
Nail positioning
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patient has sustained a closed (Tscherne Classification) or open tibial fracture (Gustillo-Anderson Classification) that is amendable for operative fixation with an intramedullary nail.
* Patient has an isolated tibia and fibula fracture
* Skeletally mature
* Patients aged between/including 18 to 70 years
* Patient has given formal consent to be involved in the trial and has completed the study consent form
* Patient is likely to comply with study follow-up requirements

Exclusion Criteria:

* Pathologic fractures
* Other fractures involving the same lower extremity
* Soft tissue injuries/problems that would prevent the surgeon from using both of the surgical techniques to insert an intramedullary nail
* Patient having pre-existing knee joint disease causing anterior knee pain
* Patient likely to have problems with follow-up
* Patient unwilling to give informed consent to be included in the trial

Primary outcomes:
measure: Anterior Knee Pain
timeFrame: 4, 6 and 12 months post-operative
Secondary outcomes:
measure: Nail positioning
timeFrame: Operation (day 1)
Other outcomes:
Locations:
city: Würselen
country: Germany
facility: Medizinisches Zentrum StädteRegion Aachen
city: Madrid
country: Spain
facility: Hoisptal de 12 Octubre
city: Valencia
country: Spain
facility: Hospital La Fe
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals
Study officials:
affiliation: Aberdeen Royal Infirmary
name: Alan Johnstone, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de 12 Octubre, Madrid
name: Pedro Caba, Dr.
role: STUDY_CHAIR
affiliation: Medizinisches Zentrum StädteRegion Aachen
name: Markus Graf, Dr.
role: STUDY_CHAIR
affiliation: HOSPITAL LA FE VALENCIA
name: Ismael Escriba, Dr.
role: STUDY_CHAIR
affiliation: Nottingham University Hospital
name: Daren Forward, MA, FRCS, DM
role: STUDY_CHAIR
References: