An observational study in Anterior Cruciate Ligament Injury, Tunneling Technique and Tendon Graft; Complication, Mechanical, sponsored by Sakarya University. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Sakarya University · Observational
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.
Functional Assessment
To evaluate postoperative functional recovery, the Lysholm Knee Score, IKDC-2000 score, and Lachman test, which are routinely used in our clinical practice, will be applied. In addition, the time required for patients to return to activities of daily living, sports participation, and their usual daily routines will be recorded. The maintenance of postoperative well-being, the time required to resume preoperative sporting activities, and whether full functional recovery is achieved will also be analyzed.
During the preoperative period, patients will undergo a detailed physical examination for knee instability. Objective instability will be assessed using a Rolimeter, and the measured anterior tibial translation will be compared with the contralateral healthy knee to determine the degree of preoperative side-to-side instability. The association between preoperative instability severity and postoperative clinical and functional outcomes will subsequently be evaluated.
Surgical and Reconstruction Technique
Anterior cruciate ligament reconstruction will be performed according to the standard surgical principles routinely applied at our institution, in accordance with current literature, evidence-based practice, and contemporary scientific recommendations. Intraoperative variables, including graft type, graft harvest site, graft size, and femoral and tibial tunnel placement, will be recorded. The relationship between these surgical parameters and postoperative clinical and functional outcomes will also be assessed.
Radiological and Clinical Follow-Up
Patients will undergo routine postoperative radiological and clinical evaluations. On postoperative day 0, standard anteroposterior and lateral knee radiographs together with routine computed tomography imaging will be obtained to assess tunnel position and the early characteristics of the reconstruction.
At the 3-month follow-up, the effectiveness of the rehabilitation program and the patient's functional status will be evaluated by physical examination, computed tomography, and radiographs. At the 6-month follow-up, return to an active lifestyle and sports participation will be assessed together with clinical and radiological findings. During follow-up, tunnel position, tunnel dimensions, graft adaptation, and the healing process will be evaluated radiologically.
Complications and Local Evaluation
Postoperative complications occurring during follow-up will be recorded in detail. These will include infection, tunnel widening, fracture, wound-healing problems, tunnel malposition, graft laxity, recurrent clinical instability, and graft rerupture. All complications will be analyzed together with clinical examination findings and radiological assessments.
Statistical Analysis
All collected data will be analyzed using appropriate statistical methods. The effects of graft type, graft size, graft harvest site, and femoral and tibial tunnel dimensions and positions on return to normal active life and sports, functional recovery, and postoperative clinical outcomes will be evaluated.
In addition, the relationship between the degree of preoperative knee instability and postoperative clinical, functional, and radiological outcomes will be statistically assessed.
Through this methodological approach, the study aims to identify factors associated with postoperative functional outcomes following anterior cruciate ligament reconstruction and to evaluate the influence of graft characteristics and femoral and tibial tunnel placement on clinical success.
521 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 169 are open to participants now.
This study's planned enrollment of 60 is below the median of 96 across 131 observational studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Sakarya University is the lead sponsor of 183 studies on the registry; 51 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
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.
ACL Reconstruction Cohort
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.
Time frame: 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.
Time frame: 1 YEAR
Return to Normal Active Life
The time required for participants to return to their normal active daily life after anterior cruciate ligament reconstruction will be recorded. This will include resumption of routine daily activities, work-related activities, and usual physical activity levels.
Time frame: 1 YEAR
Plan to share: No
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Started Jun 2026 (actual). Primary completion is estimated for Jan 2027, 7 months after the start.
Of 63 non-industry observational studies under Anterior Cruciate Ligament Injuries, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 167. This study's planned 7 months is below that.
Counting every sponsor, half of 69 studies reached it within 41 months; a quarter within 23 and three quarters within 167.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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