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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semi-extended surgical technique | Experimental | The experimental technique for implanting an intramedullary tibia nail is with the knee in 10-20 degrees of flexion. |
|
| Standard Surgical Technique | Active Comparator | The standard surgical technique in intramedullary tibia nailing is with the knee in almost 90 degrees of flexion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-extended Surgical Technique | Procedure | Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Knee Pain | Anterior Knee pain will be measured through a Kneeling test (time a patient is able to rest on his operated knee) | 4, 6 and 12 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Nail positioning | Measure by means of fluoroscopy and standard x-rays during the surgery, the position of both the guide wire and the intramedullary nail. | Operation (day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Johnstone, Professor | Aberdeen Royal Infirmary | Principal Investigator |
| Pedro Caba, Dr. | Hospital de 12 Octubre, Madrid | Study Chair |
| Markus Graf, Dr. | Medizinisches Zentrum StädteRegion Aachen | Study Chair |
| Ismael Escriba, Dr. | HOSPITAL LA FE VALENCIA | Study Chair |
| Daren Forward, MA, FRCS, DM | Nottingham University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinisches Zentrum StädteRegion Aachen | Würselen | 52146 | Germany | |||
| Hoisptal de 12 Octubre |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| Standard Surgical Technique | Procedure | Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion. |
|
|
| Madrid |
| 28041 |
| Spain |
| Hospital La Fe | Valencia | 46009 | Spain |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Nottingham University Hospitals | Nottingham | NG7 2UH | United Kingdom |