Tibial Fractures
Conditions
Keywords
Intramedullary tibia nailing, Anterior Knee Pain, Nail positioning
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.
Interventions
PROCEDURESemi-extended Surgical Technique
Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.
PROCEDUREStandard Surgical Technique
Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.
Sponsors
Smith & Nephew Orthopaedics AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Knee Pain | 4, 6 and 12 months post-operative | Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nail positioning | Operation (day 1) | Measure by means of fluoroscopy and standard x-rays during the surgery, the position of both the guide wire and the intramedullary nail. |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed