NCT07733895

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

Anterior cruciate ligament reconstructionPsychological readinessReturn to sportKinesiophobiaSubjective knee function

Outcome Measures

Primary Outcomes (1)

  • Psychological readiness to return to sport (ACL-RSI)

    Psychological readiness to return to sport assessed using the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale.

    At study assessment (single assessment performed between 3 and 24 months after ACL reconstruction)

Secondary Outcomes (4)

  • Kinesiophobia (Tampa Scale for Kinesiophobia [TSK])

    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)

    At study assessment (single assessment performed between 3 and 24 months after ACL reconstruction)

  • Sport activity level (Tegner Activity Scale)

    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

    At study assessment (single assessment performed between 3 and 24 months after primary ACL reconstruction)

Study Arms (4)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

  • Ohji 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.

  • Raizah 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.

  • Webster 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.

  • Ardern 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.

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKinesiophobia

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesPhobic DisordersAnxiety DisordersMental Disorders

Central Study Contacts

Zeynep KOLUMAN, PT, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist and PhD Student

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 29, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations