Semi-extended Position vs. 90 Degrees of Flexion for Intramedullary Nailing of the Tibia: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 95
- Locations
- 5
- Primary Endpoint
- Anterior Knee Pain
Study Overview
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:
- Nail positioning by means of intra-operative fluoroscopy and post operative x-rays.
- Anterior Knee pain by means of VAS-scores, a Kneeling test and Subjective outcomes by means of Patient questionnaires
- Knee-related adverse events
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Semi-extended surgical technique
The experimental technique for implanting an intramedullary tibia nail is with the knee in 10-20 degrees of flexion.
Intervention: Semi-extended Surgical Technique (Procedure)
Standard Surgical Technique
The standard surgical technique in intramedullary tibia nailing is with the knee in almost 90 degrees of flexion.
Intervention: Standard Surgical Technique (Procedure)
Outcomes
Primary Outcomes
Anterior Knee Pain
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)
Secondary Outcomes
- Nail positioning(Operation (day 1))