Tibia FracturesNCT07862907
Comparison of Knee Muscle Function After Suprapatellar and Infrapatellar Tibial Nailing in Patients With Tibial Shaft Fractures
An observational study of Tibia Fractures, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tibia Fractures
- What is being tested?
- Infrapatellar Tibial Intramedullary Nailing and Suprapatellar Tibial Intramedullary Nailing
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2026to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul, Şişli, 34384
Furkan Barış, MD, +905347161615, furkanbariss@gmail.com
About this study
Official title: Comparison of the Effects of Suprapatellar and Infrapatellar Tibial Intramedullary Nailing on the Knee Extensor Mechanism in Tibial Shaft Fractures
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Tibia Fractures
- Being tested
- Infrapatellar Tibial Intramedullary Nailing, Suprapatellar Tibial Intramedullary Nailing
- Keywords
- Tibial Shaft Fracture, Intramedullary nail, Suprapatellar, Infrapatellar, Knee function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrapatellar Tibial Intramedullary NailingProcedure or surgery
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.
Suprapatellar Tibial Intramedullary NailingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Infrapatellar Tibial Nailing Group | Participants with acute tibial shaft fractures who underwent intramedullary tibial nailing through an infrapatellar entry portal. Receives: Procedure: Infrapatellar Tibial Intramedullary Nailing | |
| Suprapatellar Tibial Nailing Group | Participants with acute tibial shaft fractures who underwent intramedullary tibial nailing through a suprapatellar entry portal. Receives: Procedure: Suprapatellar Tibial Intramedullary Nailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 and 6 months after surgery
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start10 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tibia FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Barış, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Müjdat Adaş, Principal investigator, Prof.Dr. Cemil Taşçıoğlu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862907
- Sponsor's protocol ID
- E-48670771-514.99-304181419
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 11294427Goodwin 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.
PubMed 30258331Vaisto 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.
PubMed 17473752
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Suprapatellar and Infrapatellar Tibial Intramedullary Nailing on the Knee Extensor Mechanism in Tibial Shaft Fractures
- ClinicalTrials.gov ID
- NCT07862907
- Acronym / sponsor ID
- E-48670771-514.99-304181419
- Conditions
- Tibia Fractures
- Keywords
- Tibial Shaft Fracture, Intramedullary nail, Suprapatellar, Infrapatellar, Knee function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infrapatellar Tibial Nailing Group | – | Procedure: Infrapatellar Tibial Intramedullary NailingParticipants with acute tibial shaft fractures who underwent intramedullary tibial nailing through an infrapatellar entry portal. |
| Suprapatellar Tibial Nailing Group | – | Procedure: Suprapatellar Tibial Intramedullary NailingParticipants with acute tibial shaft fractures who underwent intramedullary tibial nailing through a suprapatellar entry portal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrapatellar Tibial Intramedullary NailingIntramedullary 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. | Procedure or surgery | Infrapatellar Tibial Nailing Group |
| Suprapatellar Tibial Intramedullary NailingIntramedullary 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. | Procedure or surgery | Suprapatellar Tibial Nailing Group |
Primary outcome
Isokinetic Knee Extensor Muscle Strength
Time frame: 3 and 6 months after surgery
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.
8 secondary outcomes
Isokinetic Knee Flexor Muscle Strength
Time frame: 3 and 6 months after surgery
Knee Joint Position Sense Absolute Error
Time frame: 3 and 6 months after surgery
International Knee Documentation Committee Subjective Knee Evaluation Score
Time frame: 3 and 6 months after surgery
Kujala Anterior Knee Pain Scale Score
Time frame: 3 and 6 months after surgery
Anterior Knee Pain on a Visual Analog Scale
Time frame: 3 and 6 months after surgery
Knee Range of Motion
Time frame: 3 and 6 months after surgery
Thigh Circumference
Time frame: 3 and 6 months after surgery
Radiographic Fracture Healing
Time frame: 3 and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 11294427Nyland 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.
- Background: PubMed 30258331Goodwin 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.
- Background: PubMed 17473752Vaisto 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Müjdat Adaş principal investigator
Prof.Dr. Cemil Taşçıoğlu City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibia Fractures, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Furkan Barış, MD (+905347161615, furkanbariss@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic Knee Extensor Muscle Strength (time frame: 3 and 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07862907, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.