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

NCT07659899 | Active Not Recruiting

• 1 other identifier: BEA-ORT-MYY-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anterior Knee Pain; Patellar Tendon Disorder; Tibial Shaft Fractures

Keywords

Tibial intramedullary nailing; Infrapatellar tendon split; Patellar tendon elasticity; Shear-wave elastography; Anterior knee pain; Tibial shaft fracture

Outcome Measures

Primary Outcomes (1)

• 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.

  Preoperative baseline and 6 months postoperatively

Secondary Outcomes (9)

• Change in patellar tendon elasticity from baseline to 3 months

  Preoperative baseline and 3 months postoperatively

• Anterior knee pain severity

  Baseline and postoperative 6 weeks, 3 months, and 6 months

• Patellofemoral function

  Preoperative baseline, 3 months, and 6 months

• Patellar Tendon-Related Symptoms and Function

  Preoperative baseline, 3 months, and 6 months

• Active knee range of motion

  Preoperative baseline, 6 weeks, 3 months, and 6 months

Study Arms (1)

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; Diagnostic Test: Shear-wave ultrasound elastography

Interventions

Infrapatellar tendon-split tibial intramedullary nailing PROCEDURE

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.

Infrapatellar Tendon-Split Tibial Nailing Cohort

Shear-wave ultrasound elastography DIAGNOSTIC_TEST

Non-invasive shear-wave ultrasound elastography of the patellar tendon performed at predefined study visits using a standardized imaging protocol.

Infrapatellar Tendon-Split Tibial Nailing Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bagcilar Training and Research Hospital

Istanbul, Istanbul, 34320, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)