Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery

NCT07876635 | Recruiting DMC

• 1 other identifier: E-43012747-050.04-590513-450
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Anterior cruciate ligament (ACL) rupture is a common and clinically significant injury, particularly among young, active, and athletic adults, and may lead to knee instability and functional impairment. The resulting instability can limit activities of daily living and reduce sports performance, often increasing the need for surgical treatment in physically active individuals. Therefore, ACL reconstruction is widely accepted as an effective treatment option in appropriately selected patients. In the assessment of patients undergoing ACL reconstruction, not only postoperative clinical success but also the degree of preoperative instability may be important. Determining the effect of preoperative instability severity and side-to-side difference on postoperative functional outcomes, clinical recovery, radiological findings, return to daily activities, and return to sports may provide a more comprehensive and objective evaluation of surgical success. Although several studies have investigated clinical outcomes after ACL reconstruction, prospective studies evaluating the impact of preoperative instability on postoperative outcomes together with clinical, functional, and radiological parameters remain limited, particularly in our country. This prospective study aims to investigate the relationship between preoperative knee instability and postoperative clinical, functional, and radiological outcomes in patients undergoing ACL reconstruction at our institution. The findings are expected to contribute to the existing literature and provide useful information for clinical practice.

Conditions

Anterior Cruciate Ligament Injury; Tunneling Technique; Tendon Graft; Complication, Mechanical

Keywords

Anterior Cruciate Ligament; ACL Reconstruction; Femoral Tunnel; Tibial Tunnel; Tunnel Position

Outcome Measures

Primary Outcomes (2)

• Lysholm Knee Score

  Postoperative knee function will be assessed using the Lysholm Knee Score. The score ranges from 0 to 100, with higher scores indicating better knee function. The association between preoperative knee instability measured using the Rolimeter and postoperative Lysholm scores will be evaluated.

  1 YEAR

• International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score

  Postoperative knee function will be assessed using the IKDC Subjective Knee Evaluation Score. Scores range from 0 to 100, with higher scores indicating better symptoms, function, and sports activity. The relationship between preoperative knee instability and postoperative IKDC scores will be analyzed.

  1 YEAR

Secondary Outcomes (1)

• Return to Normal Active Life

  1 YEAR

Study Arms (1)

Patients Undergoing ACL Reconstruction

ACL Reconstruction Cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients diagnosed with anterior cruciate ligament (ACL) rupture who are scheduled to undergo primary ACL reconstruction at our institution. Eligible participants will be prospectively enrolled and followed postoperatively for clinical, functional, and radiological outcomes.

You may qualify if:

• Patients aged 18-50 years.
• Patients diagnosed with unilateral anterior cruciate ligament (ACL) injury.
• Patients scheduled to undergo primary ACL reconstruction.
• Patients who are willing and able to complete a postoperative follow-up period of at least 6 months.
• Patients with available postoperative radiological assessments, including computed tomography (CT), magnetic resonance imaging (MRI), and/or standard radiographs, as required by the study protocol.
• Patients with clinical outcome assessments, including the Lysholm Knee Score and International Knee Documentation Committee (IKDC) score, recorded during the planned follow-up period.

You may not qualify if:

• Patients with multiligament knee injuries, including clinically significant concomitant posterior cruciate ligament (PCL), medial collateral ligament (MCL), or lateral collateral ligament (LCL) injuries.
• Patients with a history of previous non-ACL surgery on the affected knee.
• Patients with advanced knee osteoarthritis.
• Patients who develop a postoperative infection.
• Patients with insufficient or inadequate radiological imaging data for the planned assessments.
• Patients who do not complete at least 6 months of postoperative follow-up.
• Patients with neuromuscular disorders or systemic connective tissue diseases.
• Patients with incomplete or inadequately recorded clinical outcome scores.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (2)

Sakarya Üniversitesi Eğitim Ve Araştirma Hastanesi

Sakarya, Turkey (Türkiye)

RECRUITING

Sakarya Üniversitesi Eğitim Ve Araştirma Hastanesi

Sakarya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Resident

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)