An observational study in Tibia Fractures, sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Observational
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.
Tibial shaft fractures are commonly treated with intramedullary nailing. The infrapatellar and suprapatellar approaches mainly differ in the position of the knee during surgery and the path used to enter the tibia. The infrapatellar approach is performed with the knee flexed and uses an entry point below the patella. The suprapatellar approach is performed with the knee in a semi-extended position and uses an entry point above the patella. Although previous studies have compared postoperative pain and patient-reported knee function between these approaches, evidence based on objective measurements of knee extensor muscle strength remains limited.
This is a prospective, single-center, observational cohort study conducted at Istanbul Prof. Dr. Cemil Tascioglu City Hospital. Both surgical approaches are routinely used at the study center. The treating trauma surgery team selects the surgical approach according to routine clinical judgment. The research protocol does not assign participants to an approach or alter the planned surgical treatment. After surgery, participants who provide written informed consent are classified into the suprapatellar or infrapatellar cohort according to the approach that was performed.
Postoperative care, weight-bearing progression, pain management, wound care, and rehabilitation are provided according to the institution's routine clinical practice. The same general rehabilitation principles are applied to both cohorts. Assessments are incorporated into scheduled postoperative follow-up visits. Muscle strength is measured under standardized conditions using an isokinetic dynamometer. During testing, the trunk, pelvis, and thigh are stabilized, the dynamometer axis is aligned with the lateral femoral condyle, and gravity correction is performed. Both the operated and uninjured contralateral limbs are evaluated to determine the degree of functional recovery.
Secondary assessments include knee flexor muscle strength, knee joint position sense, anterior knee pain, knee range of motion, and thigh circumference. Patient-reported knee function and symptoms are evaluated using the International Knee Documentation Committee Subjective Knee Form and the Kujala Anterior Knee Pain Scale. Anterior knee pain is also assessed using a Visual Analog Scale.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Age between 18 and 65 years Acute tibial shaft fracture classified as AO type 42 Treatment with intramedullary nailing using a suprapatellar or infrapatellar approach Provision of written informed consent to participate in the study
Exclusion Criteria:
Previous knee surgery. Concomitant knee ligament injury. Intra-articular fracture. Bilateral fractures. Neurovascular injury. Multiple trauma that may affect knee extensor strength, including an ipsilateral femoral fracture or pelvic fracture.
Participants with acute tibial shaft fractures who underwent intramedullary tibial nailing through an infrapatellar entry portal.
Procedure: Infrapatellar Tibial Intramedullary Nailing
Participants with acute tibial shaft fractures who underwent intramedullary tibial nailing through a suprapatellar entry portal.
Procedure: Suprapatellar Tibial Intramedullary Nailing
Intramedullary 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.
Intramedullary 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.
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.
Time frame: 3 and 6 months after surgery
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.
Time frame: 3 and 6 months after surgery
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.
Time frame: 3 and 6 months after surgery
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.
Time frame: 3 and 6 months after surgery
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.
Time frame: 3 and 6 months after surgery
Anterior Knee Pain on a Visual Analog Scale
Anterior knee pain in the operated limb will be assessed using a visual analog scale scored from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity. Scores will be compared between the suprapatellar and infrapatellar tibial nailing cohorts.
Time frame: 3 and 6 months after surgery
Knee Range of Motion
Knee flexion and extension range of motion will be assessed and recorded in degrees. Flexion and extension measurements will be evaluated separately and compared between the suprapatellar and infrapatellar tibial nailing cohorts.
Time frame: 3 and 6 months after surgery
Thigh Circumference
Thigh circumference will be measured and recorded in centimeters. Measurements will be compared between the suprapatellar and infrapatellar tibial nailing cohorts at each assessment time point.
Time frame: 3 and 6 months after surgery
Radiographic Fracture Healing
Fracture healing will be evaluated using anteroposterior and lateral radiographs of the operated tibia. Radiographic findings will be assessed at each follow-up time point and compared between the suprapatellar and infrapatellar tibial nailing cohorts.
Time frame: 3 and 6 months after surgery
Plan to share: Undecided — A decision regarding individual participant data sharing has not yet been made because the research team has not finalized the scope and conditions of potential data sharing. Participant consent and institutional requirements will be considered before a decision is reached.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization