Comparison of the Effects of Suprapatellar and Infrapatellar Tibial Intramedullary Nailing on the Knee Extensor Mechanism in Tibial Shaft Fractures
Sponsor study identifier
observational
60
1 country
1
Study Start
February 10, 2026
Actual (reported)Primary Completion
August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 10, 2026
Actual (reported)October 2, 2026
Actual (reported)October 7, 2026
Actual (reported)August 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
3 and 6 months after surgery
Isokinetic Knee Flexor Muscle Strength
3 and 6 months after surgery
Knee Joint Position Sense Absolute Error
3 and 6 months after surgery
International Knee Documentation Committee Subjective Knee Evaluation Score
3 and 6 months after surgery
Kujala Anterior Knee Pain Scale Score
3 and 6 months after surgery
Anterior Knee Pain on a Visual Analog Scale
3 and 6 months after surgery
Participants with acute tibial shaft fractures who underwent intramedullary tibial nailing through an infrapatellar entry portal.
Participants with acute tibial shaft fractures who underwent intramedullary tibial nailing through a suprapatellar entry portal.
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.
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.
T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul, Şişli, 34384, Turkey (Türkiye)
Nyland J, Bealle DP, Kaufer H, Johnson DL. Long-term quadriceps femoris functional deficits following intramedullary nailing of isolated tibial fractures. Int Orthop. 2001;24(6):342-6. doi: 10.1007/s002640000191.
Goodwin AI, Haws BE, Knio ZO, Moerk PK, Miller AN. Isokinetic Strength Testing Following Intramedullary Nailing of Tibial Shaft Fractures Predicts Time to Recovery and Return of Muscle Strength in the Injured Extremity: A Prospective Case Series. HSS J. 2018 Oct;14(3):266-270. doi: 10.1007/s11420-018-9611-y. Epub 2018 Apr 27.
Müjdat Adaş
Prof.Dr. Cemil Taşçıoğlu City Hospital
First Submitted
October 2, 2026
First Posted
October 7, 2026
Study Start
February 10, 2026
Actual (reported)Primary Completion
August 2027
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Vaisto O, Toivanen J, Kannus P, Jarvinen M. Anterior knee pain and thigh muscle strength after intramedullary nailing of a tibial shaft fracture: an 8-year follow-up of 28 consecutive cases. J Orthop Trauma. 2007 Mar;21(3):165-71. doi: 10.1097/BOT.0b013e31803773cd.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 7, 2026
Record last verified: 2026-10
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