NCT07851298

Brief Summary

The goal of this clinical trial is to learn whether an online mental and emotional support program called ACL Unbroken can help people recovering from ACL reconstruction surgery feel more confident and ready to return to sports when used alongside standard physical therapy. The main questions this study aims to answer are:

  • Does the ACL Unbroken program help people feel more mentally prepared and confident to return to sports after ACL surgery?
  • Does the ACL Unbroken program improve recovery outcomes, such as physical performance, return to sports participation, satisfaction with recovery, and reducing the risk of another ACL injury? Participants in the study will:
  • Continue to receive their usual physical therapy and medical care prescribed by their healthcare providers.
  • Complete surveys and assessments about their recovery, confidence, readiness to return to sports, and overall recovery experience.
  • Be assigned to one of two groups by chance.
  • If assigned to the intervention group, receive access to the ACL Unbroken online program, which includes educational lessons and activities focused on goal setting, confidence building, coping with fear of re-injury, stress management, motivation, mindfulness, meditation, visualization, and resilience during recovery.
  • If assigned to the comparison group, not receive access to the ACL Unbroken program during the study period. If there is a comparison group, researchers will compare participants who receive the ACL Unbroken program with participants who receive standard care alone to see whether the program improves psychological readiness, recovery outcomes, and return-to-sport success after ACL reconstruction surgery.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
27mo left

Started Oct 2026

Typical duration for not_applicable

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

September 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

2.1 years

First QC Date

September 25, 2026

Last Update Submit

September 25, 2026

Conditions

Anterior Cruciate Ligament ReconstructionAnterior Cruciate Ligament InjuryAnterior Cruciate Ligament TearAnterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (1)

  • Psychological Readiness to Return to Sport Following ACL Reconstruction at 12 Months

    Psychological readiness will be assessed using the Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) Scale. The ACL-RSI is a 12-item patient-reported outcome measure evaluating emotions, confidence, and risk appraisal related to returning to sport after ACL reconstruction. Scores range from 0 to 100, with higher scores indicating greater psychological readiness to return to sport. The mean ACL-RSI score at 12 months post-operatively will be reported.

    1 Year

Secondary Outcomes (2)

  • Patient-Reported Knee Function and Quality of Life Following ACL Reconstruction at 12 Months

    1 year

  • Return to Pre-Injury Level of Sport Participation at 12 Months Following ACL Reconstruction

    1 Year

Study Arms (2)

Standard of Care

NO INTERVENTION

Subjects in this arm will be randomized. They will not receive the Unbroken Athlete Program. Subjects will follow the standard of care treatment from their care team.

ACL Unbroken Athlete Program

EXPERIMENTAL

Subjects in this arm will be randomized. They will receive the Unbroken Athlete Program. Subjects will follow the standard of care treatment from their care team and complete scheduled online modules as part of the intervention.

Other: Unbroken Comeback

Interventions

Unbroken ComebackOTHER

The Unbroken Comeback is an online modular recovery program designed for athletes recovering from injury or surgery that focuses on the mental and emotional aspects of rehabilitation, not just the physical recovery. The program aims to help athletes rebuild confidence, resilience, and mindset so they can return to sport or activity stronger and more prepared.

ACL Unbroken Athlete Program

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 15 to 25 years
  • Athlete planning to return to sport after surgery
  • Undergoing primary ACL reconstruction with (BTB) Patellar tendon autograft

You may not qualify if:

  • Undergoing primary ACL Reconstruction with a graft source other than (BTB) Patellar tendon autograft
  • Multi-ligamentous knee injury requiring repair or reconstruction
  • Previous ACL Reconstruction on affected or non-affected lower extremity
  • Concomitant articular cartilage procedures
  • Patients not planning to return to sport(s) after surgery
  • Unable to consistently access wifi or a device to complete the Unbroken Athlete online modular program
  • Undergoing 1-1 coaching with a behavioral psychotherapist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inova Health System: Orthopedic, Sports Medicine

Fairfax, Virginia, 22031, United States

Location

Related Publications (13)

  • Dai W, Leng X, Wang J, Cheng J, Hu X, Ao Y. Quadriceps Tendon Autograft Versus Bone-Patellar Tendon-Bone and Hamstring Tendon Autografts for Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Oct;50(12):3425-3439. doi: 10.1177/03635465211030259. Epub 2021 Sep 8.

    PMID: 34494906BACKGROUND

  • Barie A, Sprinckstub T, Huber J, Jaber A. Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique: comparable stability, function and return-to-sport level but less donor site morbidity in athletes after 10 years. Arch Orthop Trauma Surg. 2020 Oct;140(10):1465-1474. doi: 10.1007/s00402-020-03508-1. Epub 2020 Jun 5.

    PMID: 32504178BACKGROUND

  • Belk JW, Kraeutler MJ, Carver TJ, McCarty EC. Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autograft: A Systematic Review of Randomized Controlled Trials. Arthroscopy. 2018 Apr;34(4):1358-1365. doi: 10.1016/j.arthro.2017.11.032. Epub 2018 Feb 1.

    PMID: 29366740BACKGROUND

  • Shani RH, Umpierez E, Nasert M, Hiza EA, Xerogeanes J. Biomechanical Comparison of Quadriceps and Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Arthroscopy. 2016 Jan;32(1):71-5. doi: 10.1016/j.arthro.2015.06.051. Epub 2015 Sep 14.

    PMID: 26382635BACKGROUND

  • Buller LT, Best MJ, Baraga MG, Kaplan LD. Trends in Anterior Cruciate Ligament Reconstruction in the United States. Orthop J Sports Med. 2014 Dec 26;3(1):2325967114563664. doi: 10.1177/2325967114563664. eCollection 2015 Jan.

    PMID: 26535368BACKGROUND

  • Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.

    PMID: 26920430BACKGROUND

  • Murray MM. Optimizing outcomes of ACL surgery-Is autograft reconstruction the only reasonable option? J Orthop Res. 2021 Sep;39(9):1843-1850. doi: 10.1002/jor.25128. Epub 2021 Jul 16.

    PMID: 34191344BACKGROUND

  • Eggeling L, Breer S, Drenck TC, Frosch KH, Akoto R. Double-Layered Quadriceps Tendon Autografts Provide Lower Failure Rates and Improved Clinical Results Compared With Hamstring Tendon Grafts in Revision ACL Reconstruction. Orthop J Sports Med. 2021 Dec 5;9(12):23259671211046929. doi: 10.1177/23259671211046929. eCollection 2021 Dec.

    PMID: 34901287BACKGROUND

  • Geib TM, Shelton WR, Phelps RA, Clark L. Anterior cruciate ligament reconstruction using quadriceps tendon autograft: intermediate-term outcome. Arthroscopy. 2009 Dec;25(12):1408-14. doi: 10.1016/j.arthro.2009.06.004.

    PMID: 19962067BACKGROUND

  • Smith PA, Stannard JP, Pfeiffer FM, Kuroki K, Bozynski CC, Cook JL. Suspensory Versus Interference Screw Fixation for Arthroscopic Anterior Cruciate Ligament Reconstruction in a Translational Large-Animal Model. Arthroscopy. 2016 Jun;32(6):1086-97. doi: 10.1016/j.arthro.2015.11.026. Epub 2016 Feb 4.

    PMID: 26853947BACKGROUND

  • Debarre L, Daxhelet J, DE Lavigne C, Parmentier C. Anterior cruciate ligament reconstruction with semitendinosus graft, comparative study of two tibial fixation devices. Acta Orthop Belg. 2024 Dec;90(4):595-601. doi: 10.52628/90.4.12152.

    PMID: 39869862BACKGROUND

  • Kaeding CC, Leger-St-Jean B, Magnussen RA. Epidemiology and Diagnosis of Anterior Cruciate Ligament Injuries. Clin Sports Med. 2017 Jan;36(1):1-8. doi: 10.1016/j.csm.2016.08.001. Epub 2016 Oct 4.

    PMID: 27871652RESULT

  • Winkler PW, Vivacqua T, Thomassen S, Lovse L, Lesniak BP, Getgood AMJ, Musahl V. Quadriceps tendon autograft is becoming increasingly popular in revision ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2022 Jan;30(1):149-160. doi: 10.1007/s00167-021-06478-y. Epub 2021 Feb 16.

    PMID: 33591370RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Edward S Chang, MD

    Inova Health Care Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Chang, MD

CONTACT

(571) 472-0465edward.chang@inova.org

Parth Sharma, BS

CONTACT

(571) 472-0464parth.sharma@inova.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Not Applicable. This is an open label study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomized into one of two parallel groups: (1) standard rehabilitation plus the ACL Unbroken online psychological readiness program or (2) standard rehabilitation alone. Outcomes will be assessed prospectively and compared between groups to determine the feasibility and preliminary effectiveness of the ACL Unbroken program in supporting recovery and return to sport following ACL reconstruction.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 1, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

The study team does not currently plan to share individual participant data, as preparing datasets for external distribution would require substantial administrative and resource commitments. If data sharing is pursued in the future, appropriate data-sharing mechanisms, such as a Data Use Agreement (DUA) or Collaborative Agreement, will be implemented before any data are disclosed to external parties.

Locations

US(1)