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Anterior Knee Pain and Patellar Tendon Elasticity After Infrapatellar Tendon-Split Tibial Intramedullary Nailing

17. juni 2026 opdateret af: Bagcilar Training and Research Hospital

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34320
        • Bagcilar Training and Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Procedure: Infrapatellar tendon-split tibial intramedullary nailing
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.
Diagnostisk test: Shear-wave ultrasound elastography
Non-invasive shear-wave ultrasound elastography of the patellar tendon performed at predefined study visits using a standardized imaging protocol.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in patellar tendon elasticity from baseline to 6 months
Tidsramme: 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.
Preoperative baseline and 6 months postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in patellar tendon elasticity from baseline to 3 months
Tidsramme: Preoperative baseline and 3 months postoperatively
Change in patellar tendon elasticity measured by shear-wave ultrasound elastography.
Preoperative baseline and 3 months postoperatively
Anterior knee pain severity
Tidsramme: Baseline and postoperative 6 weeks, 3 months, and 6 months
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.
Baseline and postoperative 6 weeks, 3 months, and 6 months
Patellofemoral function
Tidsramme: Preoperative baseline, 3 months, and 6 months
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.
Preoperative baseline, 3 months, and 6 months
Patellar Tendon-Related Symptoms and Function
Tidsramme: Preoperative baseline, 3 months, and 6 months
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
Preoperative baseline, 3 months, and 6 months
Active knee range of motion
Tidsramme: Preoperative baseline, 6 weeks, 3 months, and 6 months
Active knee flexion and extension lag measured with a goniometer.
Preoperative baseline, 6 weeks, 3 months, and 6 months
Patellar tendon thickness
Tidsramme: Preoperative baseline, 6 weeks, 3 months, and 6 months
Patellar tendon thickness measured on B-mode ultrasound.
Preoperative baseline, 6 weeks, 3 months, and 6 months
Doppler neovascularization
Tidsramme: Preoperative baseline, 6 weeks, 3 months, and 6 months
Semiquantitative Doppler neovascularization score.
Preoperative baseline, 6 weeks, 3 months, and 6 months
Pressure Pain Sensitivity
Tidsramme: 6 weeks, 3 months, and 6 months
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.
6 weeks, 3 months, and 6 months
Inter-rater reliability of shear-wave elastography measurements
Tidsramme: Baseline, 6 weeks, 3 months, and 6 months
Agreement between two independent radiologists assessed using intraclass correlation coefficients.
Baseline, 6 weeks, 3 months, and 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bagcilar Training and Research Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. marts 2026

Primær færdiggørelse (Anslået)

30. november 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

17. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • BEA-ORT-MYY-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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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