Semi-extended Surgical Technique
ProcedureSurgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.
Other names: Trigen META Intramedullray Tibia Nail
NCT Number: NCT01358292
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
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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Medizinisches Zentrum StädteRegion Aachen, Würselen, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.
Other names: Trigen META Intramedullray Tibia Nail
Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.
Other names: Trigen META intramedullary tibia nailing
Time frame: 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)
Time frame: 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.
Smith & Nephew Orthopaedics AG
Industry
Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial
Acronym: TrigenMETA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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