An observational study in Anterior Cruciate Ligament Injury, sponsored by Biruni University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Biruni University · Observational
The goal of this observational study is to evaluate psychological readiness, kinesiophobia, subjective knee function, sport activity level, and return-to-sport status in athletes who have undergone primary anterior cruciate ligament (ACL) reconstruction between 3 and 24 months after surgery.
The main questions it aims to answer are:
Do these outcomes differ across different postoperative time periods? Are they associated with return-to-sport status? Participants will complete questionnaires assessing psychological readiness (ACL-RSI), kinesiophobia (TSK), subjective knee function (IKDC), and sport activity level (Tegner), and will provide information about their return-to-sport status.
Anterior cruciate ligament (ACL) injury is one of the most common knee injuries in athletes participating in pivoting and cutting sports. Primary ACL reconstruction is widely performed to restore knee stability, improve functional performance, and facilitate return to sport. Despite advances in surgical techniques and rehabilitation protocols, many athletes do not return to their preinjury level of sports participation. Increasing evidence suggests that successful recovery after ACL reconstruction depends not only on physical function but also on psychological factors.
Psychological readiness to return to sport has emerged as an important determinant of rehabilitation outcomes following ACL reconstruction. Fear of reinjury, lack of confidence in the reconstructed knee, and reduced self-efficacy may delay or prevent return to sport even in individuals who demonstrate satisfactory physical recovery. Patient-reported outcome measures, including the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale, the Tampa Scale for Kinesiophobia (TSK), the International Knee Documentation Committee (IKDC) Subjective Knee Form, and the Tegner Activity Scale, are commonly used to evaluate these psychological and functional aspects of recovery.
Previous studies have reported significant relationships between psychological readiness, kinesiophobia, subjective knee function, and return-to-sport outcomes following ACL reconstruction. However, most investigations have focused on single postoperative time points or relatively homogeneous patient populations. Consequently, limited evidence is available regarding how these outcomes change throughout different stages of postoperative recovery and whether the relationships among these variables differ according to time since surgery.
The aim of this observational cross-sectional study is to evaluate psychological readiness, kinesiophobia, subjective knee function, sport activity level, and return-to-sport status in athletes who have undergone primary ACL reconstruction between 3 and 24 months after surgery. Participants will be classified according to postoperative recovery period, allowing comparisons between different stages of rehabilitation.
Psychological readiness will be evaluated using the ACL-RSI, kinesiophobia using the TSK, subjective knee function using the IKDC Subjective Knee Form, and sport activity level using the Tegner Activity Scale. Information regarding return-to-sport status and relevant demographic and clinical characteristics will also be collected. The study will investigate differences in these outcomes across postoperative recovery periods and examine the relationships between psychological and functional recovery and return-to-sport status.
The findings of this study are expected to improve understanding of the recovery process following ACL reconstruction and provide clinicians with evidence regarding the timing of psychological and functional recovery. The results may contribute to optimizing rehabilitation strategies, identifying athletes who require additional psychological support, and improving clinical decision-making related to return to sport.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's planned enrollment of 200 is above the median of 98 across 153 observational studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Biruni University is the lead sponsor of 180 studies on the registry; 45 are open to participants now.
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The study population will consist of athletes aged 18 years or older who have undergone unilateral primary anterior cruciate ligament (ACL) reconstruction and are between 3 and 24 months postoperatively. Participants must have regularly participated in sports before injury (preinjury Tegner Activity Scale score ≥4), be able to complete the study questionnaires in Turkish, and provide written informed consent.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Athletes who underwent primary anterior cruciate ligament reconstruction and are between 3 and 6 months after surgery at the time of assessment.
Athletes who underwent primary anterior cruciate ligament reconstruction and are more than 6 months but no longer than 12 months after surgery at the time of assessment.
Athletes who underwent primary anterior cruciate ligament reconstruction and are more than 12 months but no longer than 18 months after surgery at the time of assessment.
Athletes who underwent primary anterior cruciate ligament reconstruction and are more than 18 months but no longer than 24 months after surgery at the time of assessment.
Psychological readiness to return to sport [Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)]
Psychological readiness to return to sport assessed using the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale. The 12-item scale evaluates psychological readiness to return to sport following ACL injury or reconstruction, including emotional response, confidence in performance, and risk appraisal. The total score ranges from 0 to 100, with higher scores indicating greater psychological readiness to return to sport.
Time frame: At study assessment (single assessment performed between 3 and 24 months after ACL reconstruction)
Kinesiophobia (Tampa Scale for Kinesiophobia [TSK])
Kinesiophobia assessed using the Tampa Scale for Kinesiophobia (TSK). Higher scores indicate greater fear of movement and reinjury. The TSK consists of 17 items, with each item scored on a 4-point response scale. The total score ranges from 17 to 68 points. Higher scores indicate greater levels of kinesiophobia and fear of movement/reinjury, whereas lower scores indicate lower levels of kinesiophobia.
Time frame: At study assessment (single assessment performed between 3 and 24 months after ACL reconstruction)
Subjective knee function (International Knee Documentation Committee [IKDC] Subjective Knee Form)
Subjective knee function assessed using the International Knee Documentation Committee (IKDC) Subjective Knee Form. Scores range from 0 to 100, with higher scores indicating better perceived knee function.
Time frame: At study assessment (single assessment performed between 3 and 24 months after ACL reconstruction)
Sport activity level (Tegner Activity Scale)
Sport activity level assessed using the Tegner Activity Scale. The scale ranges from 0 to 10, with higher scores indicating higher levels of physical activity and sports participation.
Time frame: At study assessment (single assessment performed between 3 and 24 months after ACL reconstruction). Preinjury and current Tegner scores will be recorded to evaluate changes in activity level following primary ACL reconstruction.
Return-to-sport status
Return-to-sport status will be assessed by determining whether participants have returned to their preinjury sport and whether they have returned to their preinjury level of sports participation at the time of assessment. Return-to-sport status will be assessed by classifying participants according to whether they have not returned to sport, have returned at a lower level than before injury, or have returned to their preinjury level of sports participation.
Time frame: At study assessment (single assessment performed between 3 and 24 months after primary ACL reconstruction)
Plan to share: No
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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