Anterior Cruciate Ligament ReconstructionUnbrokenACLNCT07851298
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
A study testing Unbroken Comeback in people with Anterior Cruciate Ligament Reconstruction and Anterior Cruciate Ligament Injuries, run by Inova Health Care Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Injury
- What is being tested?
- Unbroken Comeback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15 to 25 years
- Athlete planning to return to sport after surgery
- Undergoing primary ACL reconstruction with (BTB) Patellar tendon autograft
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Inova Health System: Orthopedic, Sports Medicine
Fairfax, Virginia, 22031
Parth Sharma, BS, 571-472-0464, parth.sharma@inova.org
Edward Chang, MD, (571) 472-0465, edward.chang@inova.org
About this study
Official title: Evaluating A Comprehensive Psychological Readiness Program To Support Return To Sport After ACL Reconstruction: A Randomized Controlled Pilot Study
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:
Read more
- 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.
Read the detailed description
This study evaluates the ACL Unbroken Program, an online psychological support program, in athletes aged 15 to 25 years who are recovering from primary anterior cruciate ligament (ACL) reconstruction with a bone-patellar tendon-bone autograft. The primary objective is to assess whether adding the ACL Unbroken Program to standard postoperative rehabilitation improves psychological readiness to return to sport and patient-reported outcomes following ACL reconstruction. Secondary objectives include evaluating physical performance outcomes, return-to-sport rates, reinjury incidence, participant satisfaction with recovery, and the feasibility and adherence associated with the program.
This is a single-site, prospective, randomized controlled pilot trial enrolling approximately 30 participants. Participants will be randomized in a 1:1 ratio to receive either standard rehabilitation alone or standard rehabilitation plus access to the ACL Unbroken Program. The study uses an open-label design due to the nature of the intervention, while outcome assessors will be blinded to group assignment when feasible. Participants will be followed for up to 24 months after enrollment.
The ACL Unbroken Program is a commercially available, web-based psychological readiness platform designed to support athletes throughout ACL rehabilitation. The program provides educational content and psychological skills training focused on confidence building, fear of reinjury, resilience, emotional regulation, recovery mindset, goal setting, and return-to-sport readiness. 15 participants, randomly assigned to the intervention group will have access to the ACL Unbroken Program in addition to receiving all standard clinical care and physical therapy prescribed by their healthcare providers.
Key assessments include validated patient-reported outcome measures evaluating psychological readiness, knee function, perceived social support, resilience, and recovery experience, as well as objective physical performance assessments such as quadriceps strength testing, hop testing, agility testing, change-of-direction testing, and movement biomechanics. Long-term follow-up assessments will also evaluate return-to-sport participation, reinjury occurrence, and participant satisfaction with recovery.
Psychological readiness has emerged as a critical factor influencing successful return to sport after ACL reconstruction, yet psychological support is not routinely incorporated into many rehabilitation programs. This study aims to provide preliminary evidence regarding the effectiveness and feasibility of integrating a structured psychological readiness program into standard ACL rehabilitation. Findings from this pilot trial will help inform the design of larger future studies and may contribute to improving recovery outcomes for athletes following ACL reconstruction.
- Conditions
- Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Tear
- Being tested
- Unbroken Comeback
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Unbroken Comeback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
Secondary outcomes (2)
Patient-Reported Knee Function and Quality of Life Following ACL Reconstruction at 12 Months
Patient-reported knee function and quality of life will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS consists of five subscales: Pain, Symptoms, Activities of Daily Living, Sport and Recreation Function, and Knee-Related Quality of Life. Scores for each subscale range from 0 to 100, with higher scores indicating better knee health, function, and quality of life. Mean KOOS subscale scores at 12 months post-operatively will be reported.
Measured: 1 year
Return to Pre-Injury Level of Sport Participation at 12 Months Following ACL Reconstruction
Return to sport will be assessed as the proportion of participants who have returned to their pre-injury sport at the same or higher level of participation by 12 months following ACL reconstruction. Return-to-sport status will be determined through participant self-report and clinical follow-up assessments. Results will be reported as the percentage of participants meeting the return-to-sport criterion
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward S Chang, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851298
- Sponsor's protocol ID
- INOVA-2026-99
- Acronym
- UnbrokenACL
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34494906Barie 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.
PubMed 32504178Belk 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.
PubMed 29366740Shani 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.
PubMed 26382635Buller 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.
PubMed 26535368Sanders 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.
PubMed 26920430Murray 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.
PubMed 34191344Eggeling 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.
PubMed 34901287Geib 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.
PubMed 19962067Smith 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.
PubMed 26853947Debarre 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.
PubMed 39869862Kaeding 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.
PubMed 27871652Winkler 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.
PubMed 33591370
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating A Comprehensive Psychological Readiness Program To Support Return To Sport After ACL Reconstruction: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07851298
- Acronym / sponsor ID
- UnbrokenACL / INOVA-2026-99
- Conditions
- Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Tear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Oct 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 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.
Detailed description
This study evaluates the ACL Unbroken Program, an online psychological support program, in athletes aged 15 to 25 years who are recovering from primary anterior cruciate ligament (ACL) reconstruction with a bone-patellar tendon-bone autograft. The primary objective is to assess whether adding the ACL Unbroken Program to standard postoperative rehabilitation improves psychological readiness to return to sport and patient-reported outcomes following ACL reconstruction. Secondary objectives include evaluating physical performance outcomes, return-to-sport rates, reinjury incidence, participant satisfaction with recovery, and the feasibility and adherence associated with the program.
This is a single-site, prospective, randomized controlled pilot trial enrolling approximately 30 participants. Participants will be randomized in a 1:1 ratio to receive either standard rehabilitation alone or standard rehabilitation plus access to the ACL Unbroken Program. The study uses an open-label design due to the nature of the intervention, while outcome assessors will be blinded to group assignment when feasible. Participants will be followed for up to 24 months after enrollment.
The ACL Unbroken Program is a commercially available, web-based psychological readiness platform designed to support athletes throughout ACL rehabilitation. The program provides educational content and psychological skills training focused on confidence building, fear of reinjury, resilience, emotional regulation, recovery mindset, goal setting, and return-to-sport readiness. 15 participants, randomly assigned to the intervention group will have access to the ACL Unbroken Program in addition to receiving all standard clinical care and physical therapy prescribed by their healthcare providers.
Key assessments include validated patient-reported outcome measures evaluating psychological readiness, knee function, perceived social support, resilience, and recovery experience, as well as objective physical performance assessments such as quadriceps strength testing, hop testing, agility testing, change-of-direction testing, and movement biomechanics. Long-term follow-up assessments will also evaluate return-to-sport participation, reinjury occurrence, and participant satisfaction with recovery.
Psychological readiness has emerged as a critical factor influencing successful return to sport after ACL reconstruction, yet psychological support is not routinely incorporated into many rehabilitation programs. This study aims to provide preliminary evidence regarding the effectiveness and feasibility of integrating a structured psychological readiness program into standard ACL rehabilitation. Findings from this pilot trial will help inform the design of larger future studies and may contribute to improving recovery outcomes for athletes following ACL reconstruction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Unbroken ComebackSubjects 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. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 15 to 25 years
- Athlete planning to return to sport after surgery
- Undergoing primary ACL reconstruction with (BTB) Patellar tendon autograft
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unbroken ComebackThe 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. | Other | ACL Unbroken Athlete Program |
Primary outcome
Psychological Readiness to Return to Sport Following ACL Reconstruction at 12 Months
Time frame: 1 Year
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.
2 secondary outcomes
Patient-Reported Knee Function and Quality of Life Following ACL Reconstruction at 12 Months
Time frame: 1 year
Return to Pre-Injury Level of Sport Participation at 12 Months Following ACL Reconstruction
Time frame: 1 Year
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 15 Oct 2026.
- Background: PubMed 34494906Dai 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.
- Background: PubMed 32504178Barie 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.
- Background: PubMed 29366740Belk 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.
- Background: PubMed 26382635Shani 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.
- Background: PubMed 26535368Buller 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.
- Background: PubMed 26920430Sanders 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.
- Background: PubMed 34191344Murray 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.
- Background: PubMed 34901287Eggeling 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.
- Background: PubMed 19962067Geib 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.
- Background: PubMed 26853947Smith 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.
- Background: PubMed 39869862Debarre 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.
- Results publication: PubMed 27871652Kaeding 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Anterior Cruciate Ligament Reconstruction
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
Not yet recruiting
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction Rehabilitation, Dry Needling
Recruiting
The Effect of Isokinetic Vs Plyometric Training in Post-ACLR Surgery
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Reconstruction Rehabilitation
RecruitingObservational study
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
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.
Edward S Chang, MD principal investigator
Inova Health Care Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unbroken Comeback in people with Anterior Cruciate Ligament Reconstruction and Anterior Cruciate Ligament Injuries, run by Inova Health Care Services at 1 site in United States.
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 3 inclusion and 7 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 15 Oct 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 United States. 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 Edward Chang, MD ((571) 472-0465, edward.chang@inova.org), 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 Following ACL Reconstruction at 12 Months (time frame: 1 Year). 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 NCT07851298, which also lists 13 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 15 Oct 2026.