Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 9:07 PM
Study NCT ID:
NCT01358292
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2011-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails
Sponsor:
Smith & Nephew Orthopaedics AG
Organization:
Study Overview
Official Title:
Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TrigenMETA
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(90ยบ 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
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: