Anterior Knee PainNCT07659899
Anterior Knee Pain and Patellar Tendon Elasticity After Infrapatellar Tendon-Split Tibial Intramedullary Nailing
An observational study of Anterior Knee Pain and Patellar Tendon Disorder, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective single-center observational cohort study will evaluate the relationship between anterior knee pain and patellar tendon elasticity after infrapatellar tendon-split tibial intramedullary nailing. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Knee Pain, Patellar Tendon Disorder, Tibial Shaft Fractures
- What is being tested?
- Infrapatellar tendon-split tibial intramedullary nailing and Shear-wave ultrasound elastography
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2025to 31 Dec 2026
- 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: Adults with unilateral tibial shaft or metaphyseal fractures treated at Bagcilar Training and Research Hospital with standard infrapatellar tendon-split tibial intramedullary nailing will be enrolled prospectively after ethics approval.
Who may be able to join
- Age 18 to 65 years
- Unilateral tibial shaft or metaphyseal fracture
- Planned treatment with infrapatellar tendon-split tibial intramedullary nailing
- Ability to complete baseline and follow-up assessments
- Written informed consent
Who cannot join
- Previous surgery on the same knee
- Previous patellar tendon rupture or known patellar tendon disorder
- Active inflammatory rheumatologic disease
- Chronic systemic corticosteroid therapy or long-term immunosuppressive treatment
- Significant peripheral neuropathy or advanced diabetic neuropathy
- Bilateral tibial fracture
- Additional major lower-extremity injury or surgery affecting assessment
- Inability to comply with scheduled follow-up visits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training and Research Hospital
Istanbul, Istanbul, 34320
About this study
Official title: Relationship Between Anterior Knee Pain and Patellar Tendon Elasticity After Infrapatellar Tendon-Split Tibial Intramedullary Nailing: A Prospective Cohort Study Using Shear-Wave Ultrasound Elastography
This prospective single-center observational cohort study will evaluate the relationship between anterior knee pain and patellar tendon elasticity after infrapatellar tendon-split tibial intramedullary nailing. Adult patients undergoing standard tibial intramedullary nailing through an infrapatellar tendon-split approach will be enrolled after ethics approval. Patellar tendon elasticity will be assessed using shear-wave ultrasound elastography before surgery and during follow-up at 6 weeks, 3 months, and 6 months. Clinical outcomes will include anterior knee pain severity, patellofemoral function, tendon-related symptoms, and knee range of motion. Inter-rater reliability between two independent radiologists will also be evaluated.
Read the detailed description
Anterior knee pain is a frequent complaint after tibial intramedullary nailing, but the role of patellar tendon biomechanical changes remains unclear. The infrapatellar tendon-split approach may lead to tendon healing, remodeling, and fibrosis, which could alter tendon elasticity and contribute to persistent pain and functional limitation. This study aims to prospectively investigate whether changes in patellar tendon elasticity are associated with anterior knee pain after infrapatellar tendon-split tibial intramedullary nailing.
This is a prospective, single-center, non-interventional observational cohort study. Adult patients aged 18 to 65 years with unilateral tibial shaft or metaphyseal fractures treated with standard infrapatellar tendon-split tibial intramedullary nailing will be enrolled consecutively after institutional ethics approval. Only patients enrolled after ethics approval will be included in the registered cohort.
Patellar tendon elasticity will be measured using shear-wave ultrasound elastography at four predefined time points: preoperatively, 6 weeks, 3 months, and 6 months postoperatively. Ultrasound assessments will be performed according to a standardized protocol by two independent radiologists, and inter-rater reliability will be assessed. Additional ultrasound parameters will include tendon thickness on B-mode imaging and Doppler neovascularization.
Clinical outcomes will include anterior knee pain assessed with a visual analog scale, patellofemoral function assessed with the Kujala Anterior Knee Pain Scale, tendon-related symptoms assessed with the VISA-P questionnaire, pressure pain sensitivity, and active knee range of motion. The primary objective is to determine whether change in patellar tendon elasticity is associated with anterior knee pain at 6 months. Secondary objectives are to examine associations between tendon elasticity and functional scores, range of motion, tendon thickness, Doppler findings, and inter-rater measurement reliability.
- Being tested
- Infrapatellar tendon-split tibial intramedullary nailing, Shear-wave ultrasound elastography
- Keywords
- Tibial intramedullary nailing, Infrapatellar tendon split, Patellar tendon elasticity, Shear-wave elastography, Anterior knee pain, Tibial shaft fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrapatellar tendon-split tibial intramedullary nailingProcedure or surgery
Standard-of-care tibial intramedullary nailing performed through an infrapatellar longitudinal patellar tendon split approach. The procedure is not assigned by the protocol; only patients undergoing this routine surgical approach are observed.
Shear-wave ultrasound elastographyDiagnostic test
Non-invasive shear-wave ultrasound elastography of the patellar tendon performed at predefined study visits using a standardized imaging protocol.
| Study group | Role | What they receive |
|---|---|---|
| Infrapatellar Tendon-Split Tibial Nailing Cohort | Adult patients with unilateral tibial shaft or metaphyseal fractures treated with standard infrapatellar tendon-split tibial intramedullary nailing after ethics approval. Participants will be followed prospectively with shear-wave ultrasound elastography and clinical assessments at baseline, 6 weeks, 3 months, and 6 months. Receives: Procedure: Infrapatellar tendon-split tibial intramedullary nailing; Diagnostic Test: Shear-wave ultrasound elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patellar tendon elasticity from baseline to 6 months
Patellar tendon elasticity measured by shear-wave ultrasound elastography in kilopascals. The primary analysis will assess the longitudinal change from baseline to 6 months.
Measured: Preoperative baseline and 6 months postoperatively
Secondary outcomes (9)
Change in patellar tendon elasticity from baseline to 3 months
Change in patellar tendon elasticity measured by shear-wave ultrasound elastography.
Measured: Preoperative baseline and 3 months postoperatively
Anterior knee pain severity
Anterior knee pain severity will be assessed using the Visual Analog Scale. The Visual Analog Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse anterior knee pain.
Measured: Baseline and postoperative 6 weeks, 3 months, and 6 months
Patellofemoral function
Patellofemoral function will be assessed using the Kujala Anterior Knee Pain Scale. The scale ranges from 0 to 100 points, with higher scores indicating better patellofemoral function and fewer anterior knee symptoms.
Measured: Preoperative baseline, 3 months, and 6 months
Patellar Tendon-Related Symptoms and Function
Patellar tendon-related symptoms and function will be assessed using the Victorian Institute of Sport Assessment-Patella questionnaire. The questionnaire ranges from 0 to 100 points, with higher scores indicating fewer patellar tendon-related symptoms and better function
Measured: Preoperative baseline, 3 months, and 6 months
Active knee range of motion
Active knee flexion and extension lag measured with a goniometer.
Measured: Preoperative baseline, 6 weeks, 3 months, and 6 months
Patellar tendon thickness
Patellar tendon thickness measured on B-mode ultrasound.
Measured: Preoperative baseline, 6 weeks, 3 months, and 6 months
Doppler neovascularization
Semiquantitative Doppler neovascularization score.
Measured: Preoperative baseline, 6 weeks, 3 months, and 6 months
Pressure Pain Sensitivity
Pressure pain sensitivity will be assessed by recording pain intensity during a standardized pressure pain assessment using the Visual Analog Scale. The Visual Analog Scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pressure pain sensitivity.
Measured: 6 weeks, 3 months, and 6 months
Inter-rater reliability of shear-wave elastography measurements
Agreement between two independent radiologists assessed using intraclass correlation coefficients.
Measured: Baseline, 6 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start5 Dec 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Knee PainStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659899
- Sponsor's protocol ID
- BEA-ORT-MYY-01
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a single-center study with a limited sample size and no predefined external data-sharing agreement. Only aggregate, de-identified study results will be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Anterior Knee Pain and Patellar Tendon Elasticity After Infrapatellar Tendon-Split Tibial Intramedullary Nailing: A Prospective Cohort Study Using Shear-Wave Ultrasound Elastography
- ClinicalTrials.gov ID
- NCT07659899
- Acronym / sponsor ID
- BEA-ORT-MYY-01
- Keywords
- Tibial intramedullary nailing, Infrapatellar tendon split, Patellar tendon elasticity, Shear-wave elastography, Anterior knee pain, Tibial shaft fracture
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jun 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.
This prospective single-center observational cohort study will evaluate the relationship between anterior knee pain and patellar tendon elasticity after infrapatellar tendon-split tibial intramedullary nailing. Adult patients undergoing standard tibial intramedullary nailing through an infrapatellar tendon-split approach will be enrolled after ethics approval. Patellar tendon elasticity will be assessed using shear-wave ultrasound elastography before surgery and during follow-up at 6 weeks, 3 months, and 6 months. Clinical outcomes will include anterior knee pain severity, patellofemoral function, tendon-related symptoms, and knee range of motion. Inter-rater reliability between two independent radiologists will also be evaluated.
Detailed description
Anterior knee pain is a frequent complaint after tibial intramedullary nailing, but the role of patellar tendon biomechanical changes remains unclear. The infrapatellar tendon-split approach may lead to tendon healing, remodeling, and fibrosis, which could alter tendon elasticity and contribute to persistent pain and functional limitation. This study aims to prospectively investigate whether changes in patellar tendon elasticity are associated with anterior knee pain after infrapatellar tendon-split tibial intramedullary nailing.
This is a prospective, single-center, non-interventional observational cohort study. Adult patients aged 18 to 65 years with unilateral tibial shaft or metaphyseal fractures treated with standard infrapatellar tendon-split tibial intramedullary nailing will be enrolled consecutively after institutional ethics approval. Only patients enrolled after ethics approval will be included in the registered cohort.
Patellar tendon elasticity will be measured using shear-wave ultrasound elastography at four predefined time points: preoperatively, 6 weeks, 3 months, and 6 months postoperatively. Ultrasound assessments will be performed according to a standardized protocol by two independent radiologists, and inter-rater reliability will be assessed. Additional ultrasound parameters will include tendon thickness on B-mode imaging and Doppler neovascularization.
Clinical outcomes will include anterior knee pain assessed with a visual analog scale, patellofemoral function assessed with the Kujala Anterior Knee Pain Scale, tendon-related symptoms assessed with the VISA-P questionnaire, pressure pain sensitivity, and active knee range of motion. The primary objective is to determine whether change in patellar tendon elasticity is associated with anterior knee pain at 6 months. Secondary objectives are to examine associations between tendon elasticity and functional scores, range of motion, tendon thickness, Doppler findings, and inter-rater measurement reliability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infrapatellar Tendon-Split Tibial Nailing Cohort | – | Procedure: Infrapatellar tendon-split tibial intramedullary nailing, Diagnostic Test: Shear-wave ultrasound elastographyAdult patients with unilateral tibial shaft or metaphyseal fractures treated with standard infrapatellar tendon-split tibial intramedullary nailing after ethics approval. Participants will be followed prospectively with shear-wave ultrasound elastography and clinical assessments at baseline, 6 weeks, 3 months, and 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with unilateral tibial shaft or metaphyseal fractures treated at Bagcilar Training and Research Hospital with standard infrapatellar tendon-split tibial intramedullary nailing will be enrolled prospectively after ethics approval.
Key inclusion criteria (5 listed)
- Age 18 to 65 years
- Unilateral tibial shaft or metaphyseal fracture
- Planned treatment with infrapatellar tendon-split tibial intramedullary nailing
- Ability to complete baseline and follow-up assessments
- Written informed consent
Key exclusion criteria (8 listed)
- Previous surgery on the same knee
- Previous patellar tendon rupture or known patellar tendon disorder
- Active inflammatory rheumatologic disease
- Chronic systemic corticosteroid therapy or long-term immunosuppressive treatment
- Significant peripheral neuropathy or advanced diabetic neuropathy
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 tendon-split tibial intramedullary nailingStandard-of-care tibial intramedullary nailing performed through an infrapatellar longitudinal patellar tendon split approach. The procedure is not assigned by the protocol; only patients undergoing this routine surgical approach are observed. | Procedure or surgery | Infrapatellar Tendon-Split Tibial Nailing Cohort |
| Shear-wave ultrasound elastographyNon-invasive shear-wave ultrasound elastography of the patellar tendon performed at predefined study visits using a standardized imaging protocol. | Diagnostic test | Infrapatellar Tendon-Split Tibial Nailing Cohort |
Primary outcome
Change in patellar tendon elasticity from baseline to 6 months
Time frame: Preoperative baseline and 6 months postoperatively
Patellar tendon elasticity measured by shear-wave ultrasound elastography in kilopascals. The primary analysis will assess the longitudinal change from baseline to 6 months.
9 secondary outcomes
Change in patellar tendon elasticity from baseline to 3 months
Time frame: Preoperative baseline and 3 months postoperatively
Anterior knee pain severity
Time frame: Baseline and postoperative 6 weeks, 3 months, and 6 months
Patellofemoral function
Time frame: Preoperative baseline, 3 months, and 6 months
Patellar Tendon-Related Symptoms and Function
Time frame: Preoperative baseline, 3 months, and 6 months
Active knee range of motion
Time frame: Preoperative baseline, 6 weeks, 3 months, and 6 months
Patellar tendon thickness
Time frame: Preoperative baseline, 6 weeks, 3 months, and 6 months
Doppler neovascularization
Time frame: Preoperative baseline, 6 weeks, 3 months, and 6 months
Pressure Pain Sensitivity
Time frame: 6 weeks, 3 months, and 6 months
Inter-rater reliability of shear-wave elastography measurements
Time frame: Baseline, 6 weeks, 3 months, and 6 months
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 26 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a single-center study with a limited sample size and no predefined external data-sharing agreement. Only aggregate, de-identified study results will be reported in publications and presentations.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Anterior Knee Pain and Patellar Tendon Disorder, run by Bagcilar Training and Research Hospital 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patellar tendon elasticity from baseline to 6 months (time frame: Preoperative baseline and 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.