About this trial
The goal of this observational study is to compare the recovery of knee muscle strength and function in adults aged 18 to 65 years with a fracture in the middle part of the shinbone. All participants are treated with an intramedullary nail, which is a metal rod placed inside the shinbone. The nail is inserted through a surgical opening either above or below the kneecap.
The main question this study aims to answer is:
Does the recovery of the muscles that straighten the knee differ between the suprapatellar approach, performed above the kneecap, and the infrapatellar approach, performed below the kneecap?
Researchers will compare participants who received the suprapatellar approach with those who received the infrapatellar approach. The treating surgical team chooses the approach as part of routine medical care. The researchers do not assign participants to either surgical approach.
Participants will attend routine follow-up visits at 3 and 6 months after surgery. During these visits, researchers will:
Measure the strength of the muscles that bend and straighten the knee and compare the operated leg with the uninjured leg Assess the participant's ability to sense the position of the knee Measure knee movement and thigh circumference Ask participants about knee function and pain in the front of the knee
The researchers expect that recovery of the muscles that straighten the knee may differ between the two surgical approaches.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients aged 18 to 65 years with acute tibial shaft fractures (AO type 42) treated with suprapatellar or infrapatellar intramedullary nailing at the Department of Orthopedics and Traumatology, Prof. Dr. Cemil Tascioglu City Hospital, Istanbul, Türkiye. The surgical approach is selected by the treating surgical team as part of routine clinical care, independently of study participation. Patients are assessed for eligibility after surgery and enrolled after providing written informed consent.
Trial design
Cohort
Prospective
Treatments tested in this trial
Infrapatellar Tibial Intramedullary Nailing
Procedure/SurgeryIntramedullary fixation of a tibial shaft fracture using an infrapatellar entry portal with the knee positioned in flexion. The procedure is performed as part of routine clinical care. The treating surgical team selects the approach independently of the research protocol.
Suprapatellar Tibial Intramedullary Nailing
Procedure/SurgeryIntramedullary fixation of a tibial shaft fracture using a suprapatellar entry portal with the knee positioned in semi-extension. The procedure is performed as part of routine clinical care. The treating surgical team selects the approach independently of the research protocol.
Treatment groups
Trial outcomes
Primary outcomes
Isokinetic Knee Extensor Muscle Strength
Knee extensor muscle strength will be assessed using an isokinetic dynamometer at angular velocities of 60 and 180 degrees per second. Measurements will be performed on both the operated and contralateral uninjured limbs at postoperative months 3 and 6. Results will be compared between the suprapatellar and infrapatellar tibial nailing cohorts.
Secondary outcomes
Isokinetic Knee Flexor Muscle Strength
Knee flexor muscle strength will be assessed using an isokinetic dynamometer at angular velocities of 60 and 180 degrees per second. Measurements will be performed on both the operated and contralateral uninjured limbs. Results at each angular velocity and assessment time point will be compared between the suprapatellar and infrapatellar tibial nailing cohorts.
Knee Joint Position Sense Absolute Error
Knee joint position sense will be assessed using an isokinetic dynamometer in continuous passive motion mode at 2 degrees per second. Following familiarization with a target position of 30 degrees of knee flexion, participants will indicate when they perceive that the target position has been reached during passive movement. The absolute difference between the target and perceived positions will be recorded in degrees. The mean absolute error of three trials will be calculated separately for each limb. Lower values indicate more accurate joint position sense.
International Knee Documentation Committee Subjective Knee Evaluation Score
Patient-reported knee symptoms, function, and sports activity will be assessed using the Turkish version of the International Knee Documentation Committee Subjective Knee Evaluation Form. The total score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms. Scores will be compared between the suprapatellar and infrapatellar tibial nailing cohorts.
Kujala Anterior Knee Pain Scale Score
Anterior knee symptoms and related functional limitations will be assessed using the Turkish version of the 13-item Kujala Anterior Knee Pain Scale. The total score ranges from 0 to 100, with higher scores indicating fewer symptoms and better function. Scores will be compared between the suprapatellar and infrapatellar tibial nailing cohorts.
Sponsors and contacts
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