Anterior Cruciate Ligament InjuryNCT07733895
Psychological Readiness and Return to Sport After ACL Reconstruction
An observational study of Anterior Cruciate Ligament Injury, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥18 years.
- History of unilateral primary anterior cruciate ligament (ACL) reconstruction.
- Between 3 and 24 months after ACL reconstruction at the time of assessment.
- Regular participation in sports before ACL injury with a preinjury Tegner Activity Scale score of ≥4.
- Ability to read and understand Turkish and independently complete the study questionnaires.
- Willingness to participate in the study.
- Provision of written informed consent.
Who cannot join
- Revision ACL reconstruction.
- Reinjury or graft rupture of the reconstructed ACL.
- Bilateral ACL injury.
- History of ACL reconstruction in the contralateral knee.
- Concomitant major ligament, cartilage, bone, or extensor mechanism surgery that is expected to substantially affect rehabilitation, weight-bearing status, return-to-sport timing, or knee function following primary ACL reconstruction.
- Other lower-extremity injuries or surgical conditions unrelated to ACL reconstruction that limit sports participation at the time of assessment.
- Neurological, rheumatologic, cardiopulmonary, or other severe systemic diseases that substantially limit sports participation.
- Cognitive, psychiatric, or communication disorders that preclude reliable completion of the study questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University
Istanbul
Zeynep KOLUMAN, PT, Mac, +905377309047, zeynep.koluman@istanbul.edu.tr
About this study
Official title: Evaluation of Psychological Readiness, Kinesiophobia, Subjective Knee Function, and Return-to-Sport Status Across Different Postoperative Periods Following Primary Anterior Cruciate Ligament Reconstruction
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.
Read the detailed description
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.
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- Anterior cruciate ligament reconstruction, Psychological readiness, Return to sport, Kinesiophobia, Subjective knee function
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative 3-6 Months | Athletes who underwent primary anterior cruciate ligament reconstruction and are between 3 and 6 months after surgery at the time of assessment. | |
| Postoperative >6-12 Months | 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. | |
| Postoperative >12-18 Months | 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. | |
| Postoperative >18-24 Months | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At study assessment (single assessment performed between 3 and 24 months after ACL reconstruction)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At study assessment (single assessment performed between 3 and 24 months after primary ACL reconstruction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Koluman, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733895
- Sponsor's protocol ID
- ACL-RTS-2026
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alswat MM, Khojah O, Alswat AM, Alghamdi A, Almadani MS, Alshibely A, Dabroom AA, Algarni HM, Alshehri MS. Returning to Sport After Anterior Cruciate Ligament Reconstruction in Physically Active Individuals. Cureus. 2020 Sep 15;12(9):e10466. doi: 10.7759/cureus.10466.
PubMed 33083169Ohji S, Aizawa J, Hirohata K, Ohmi T, Mitomo S, Koga H, Yagishita K. Changes in subjective knee function and psychological status from preoperation to 6 months post anterior cruciate ligament reconstruction. J Exp Orthop. 2022 Dec 1;9(1):114. doi: 10.1186/s40634-022-00551-2.
PubMed 36454346Raizah A, Alhefzi A, Alshubruqi AAM, Hoban MAMA, Ahmad I, Ahmad F. Perceived Kinesiophobia and Its Association with Return to Sports Activity Following Anterior Cruciate Ligament Reconstruction Surgery: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Aug 30;19(17):10776. doi: 10.3390/ijerph191710776.
PubMed 36078492Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008 Feb;9(1):9-15. doi: 10.1016/j.ptsp.2007.09.003. Epub 2007 Nov 5.
PubMed 19083699Ardern CL, Webster KE, Taylor NF, Feller JA. Return to sport following anterior cruciate ligament reconstruction surgery: a systematic review and meta-analysis of the state of play. Br J Sports Med. 2011 Jun;45(7):596-606. doi: 10.1136/bjsm.2010.076364. Epub 2011 Mar 11.
PubMed 21398310
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Psychological Readiness, Kinesiophobia, Subjective Knee Function, and Return-to-Sport Status Across Different Postoperative Periods Following Primary Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07733895
- Acronym / sponsor ID
- ACL-RTS-2026
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- Anterior cruciate ligament reconstruction, Psychological readiness, Return to sport, Kinesiophobia, Subjective knee function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Postoperative 3-6 Months | – | –Athletes who underwent primary anterior cruciate ligament reconstruction and are between 3 and 6 months after surgery at the time of assessment. |
| Postoperative >6-12 Months | – | –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. |
| Postoperative >12-18 Months | – | –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. |
| Postoperative >18-24 Months | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- Age ≥18 years.
- History of unilateral primary anterior cruciate ligament (ACL) reconstruction.
- Between 3 and 24 months after ACL reconstruction at the time of assessment.
- Regular participation in sports before ACL injury with a preinjury Tegner Activity Scale score of ≥4.
- Ability to read and understand Turkish and independently complete the study questionnaires.
Key exclusion criteria (8 listed)
- Revision ACL reconstruction.
- Reinjury or graft rupture of the reconstructed ACL.
- Bilateral ACL injury.
- History of ACL reconstruction in the contralateral knee.
- Concomitant major ligament, cartilage, bone, or extensor mechanism surgery that is expected to substantially affect rehabilitation, weight-bearing status, return-to-sport timing, or knee function following primary ACL reconstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychological readiness to return to sport [Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)]
Time frame: At study assessment (single assessment performed between 3 and 24 months after ACL reconstruction)
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.
4 secondary outcomes
Kinesiophobia (Tampa Scale for Kinesiophobia [TSK])
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)
Time frame: At study assessment (single assessment performed between 3 and 24 months after ACL reconstruction)
Sport activity level (Tegner Activity Scale)
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
Time frame: At study assessment (single assessment performed between 3 and 24 months after primary ACL reconstruction)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Results publication: PubMed 33083169Alswat MM, Khojah O, Alswat AM, Alghamdi A, Almadani MS, Alshibely A, Dabroom AA, Algarni HM, Alshehri MS. Returning to Sport After Anterior Cruciate Ligament Reconstruction in Physically Active Individuals. Cureus. 2020 Sep 15;12(9):e10466. doi: 10.7759/cureus.10466.
- Results publication: PubMed 36454346Ohji S, Aizawa J, Hirohata K, Ohmi T, Mitomo S, Koga H, Yagishita K. Changes in subjective knee function and psychological status from preoperation to 6 months post anterior cruciate ligament reconstruction. J Exp Orthop. 2022 Dec 1;9(1):114. doi: 10.1186/s40634-022-00551-2.
- Results publication: PubMed 36078492Raizah A, Alhefzi A, Alshubruqi AAM, Hoban MAMA, Ahmad I, Ahmad F. Perceived Kinesiophobia and Its Association with Return to Sports Activity Following Anterior Cruciate Ligament Reconstruction Surgery: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Aug 30;19(17):10776. doi: 10.3390/ijerph191710776.
- Results publication: PubMed 19083699Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008 Feb;9(1):9-15. doi: 10.1016/j.ptsp.2007.09.003. Epub 2007 Nov 5.
- Results publication: PubMed 21398310Ardern CL, Webster KE, Taylor NF, Feller JA. Return to sport following anterior cruciate ligament reconstruction surgery: a systematic review and meta-analysis of the state of play. Br J Sports Med. 2011 Jun;45(7):596-606. doi: 10.1136/bjsm.2010.076364. Epub 2011 Mar 11.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injury, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep KOLUMAN, PT, MSc (+905377309047, zeynep.koluman@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological readiness to return to sport [Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)] (time frame: At study assessment (single assessment performed between 3 and 24 months after ACL reconstruction)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07733895, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.