ACL ReconstructionROAR 3NCT07476430
Readiness Outcomes Affecting Return to Sport 3.0
A study testing Mental Skills Training (MST) in people with ACL Reconstruction, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The primary aim is to determine if MST will improve coping skills in young athletes returning to sport after ACLR as measured by ACSI-28. Participants will undergo MST led by masters-level mental skills specialist pre-operatively, 3 months, 6 months, and 9 months post-operatively. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- ACL Reconstruction
- What is being tested?
- Mental Skills Training (MST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Jun 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 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of a complete ACL tear
- Undergoing ACL reconstruction at Boston Children's Hospital by a study-participating surgeon
- Age at time of surgery between 8 and <=25
- English-speaking patient
Who cannot join
- Previous ACL tear
- Torn MCL, LCL, or PCL that require reconstruction in addition to ACL
- Non-English speaking patient/family
- Lack of intention to return to sports/sporting activities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dai M Sugimoto, PhD contact
United States1 site
Boston Children's Waltham
Waltham, Massachusetts, 02453
Angelina M Sala, BS, 720-340-6205, angie.sala@childrens.harvard.edu
Matthew D. Milewski, MD
About this study
The primary aim is to determine if MST will improve coping skills in young athletes returning to sport after ACLR as measured by ACSI-28. Participants will undergo MST led by masters-level mental skills specialist pre-operatively, 3 months, 6 months, and 9 months post-operatively. Power analysis suggested at least 52 pairs are needed (α=0.05, β=0.80). There will be 65 patients enrolled in both the MST group and the control group (no MST) for a total of 130 patients. This will allow for a 4-point difference in ACSI and a 20% dropout rate.
The secondary aim is to determine if MST will improve psychological readiness and athletic identity as well as decrease psychological stress, anxiety, depression, and PTSD symptoms of young athletes returning to sport after ACLR as measured by ACL-RSI, AIMS, PROMIS-PSE, GAD-7, PHQ-9, and CRIES, respectively.
- Conditions
- ACL Reconstruction
- Being tested
- Mental Skills Training (MST)
- Keywords
- psychological readiness, mental skills training, pediatric, adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Skills Training (MST)Behavioural
Mental skills training aims to enhance coping strategies, motivation, and confidence. MST has been identified as a potential way to improve an athlete's psychological readiness both prior to injury a
| Study group | Role | What they receive |
|---|---|---|
| Mental Skills Training (MST) Cohort | Experimental | This group will receive MST. The enrollment will be randomized by the treating surgeon. Receives: Behavioral: Mental Skills Training (MST) |
| Non-MST Cohort | No intervention | This cohort will not receive mental skills training. The enrollment will be randomized by treating surgeon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Athletic Coping Skills Inventory (ACSI-28)
A questionnaire to assess the psychological skills and coping strategies employed by athletes. Scored on a 28-point scale, where higher scores indicate a greater ability to cope.
Measured: The ACSI-28 will be administered preoperatively (baseline) and 9 months, 1 year, and 2 years post operatively.
Secondary outcomes (8)
The Anterior Cruciate Ligament Return to Sport after Injury Scale (ACL-RSI)
A questionnaire to measure the psychological impact of returning to sport after ACL reconstruction surgery. Scored on a 100-point scale, where higher score indicates greater psychological readiness to return to sport.
Measured: The ACL-RSI will be administered preoperatively (baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively.
The Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS)
A questionnaire to quantify the activity of children between 10 and 18 years old.
Scored on a 30-point scale, where higher scores indicate more physical activity.
Measured: The Pedi-FABS will be assessed at baseline, 6 months, 9 months, 1 year, and 2 years
PROMIS Psychological Stress Experiences (PROMIS-PSE)
A questionnaire to assess the patient's psychological stress experiences. Scored on a 100-point scale, where 50 is a normative value and higher scores indicate worse psychological stress.
Measured: The PROMIS-PSE will be assessed at baseline, 3 months, 6 months, 9 months, 1 year, and 2 years.
Child Revised Impact of Events Scale (CRIES)
A questionnaire to screen children for Post-Traumatic Stress Disorder (PTSD). Scored on a 65-point scale, where >30 indicates PTSD symptoms.
Measured: The CRIES will be administered preoperatively (baseline), 3 months, and 6 months.
General Anxiety Disorder-7 (GAD-7)
A questionnaire to measure anxiety severity. Scored on a 21-point scale, where higher scores indicate greater states of anxiety.
Measured: The GAD-7 will be administered preoperatively (baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively.
Patient Health Questionnaire-9 (PHQ-9)
A questionnaire to measure depression severity. Scored on a 27-point scale, where higher scores indicate greater states of depression.
Measured: The PHQ-9 will be administered preoperatively (baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively.
Athletic Identity Measurement Scale (AIMS)
A questionnaire to measure the degree to which an individual's identity is tied to being an athlete. Scored on a 10-point scale, where higher scores indicate stronger identification.
Measured: The AIMS will be administered preoperatively (baseline) and at 1 year and 2 years postoperatively.
International Knee Documentation Committee (IKDC) or the Pedi-IKDC
A questionnaire to assess the symptoms and function of the knee during daily activities in patients over the age of 18. The Pedi-IKDC is a modified version of the IKDC questionnaire for patients ages 10-18. Scored on a 100-point scale, where higher scores indicate less pain and higher functioning.
Measured: The Pedi-IKDC will be administered preoperatively (baseline) and at 6 months, 9 months, 1 year, and 2 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for ACL ReconstructionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One cohort will receive mental skills training. The other cohort will not receive mental skills training.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Milewski, Boston Children's Hospital
- Investigators
- Matthew D Milewski, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476430
- Sponsor's protocol ID
- IRB-P00052897
- Other IDs
- 1579291
- Acronym
- ROAR 3
- Status last verified
- Oct 2025
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that will be shared will be de-identified and for manuscript and publishing purposes only. PHI data will not be accessible outside of the research team, and only de-identified data will be a part of the manuscript.
Publications
Griffith K, O'Brien K, McGurty S, Miller P, Christino MA. The Efficacy of a Mental Skills Training Course for Collegiate Athletes. J Athl Train. 2024 Jul 1;59(7):772-778. doi: 10.4085/1062-6050-0533.22.
PubMed 38014800Mercurio AM, Scott EJ, Sugimoto D, Christino MA, Coene RP, Gossman EC, Cook DL, Kocher MS, Kramer DE, Yen YM, Micheli LJ, Milewski MD. Assessing the Impact of Psychological Readiness on Performance and Symmetry in Functional Testing After ACL Reconstruction in Pediatric and Adolescent Patients. Orthop J Sports Med. 2024 Sep 27;12(9):23259671241274768. doi: 10.1177/23259671241274768. eCollection 2024 Sep.
PubMed 39359482McPherson AL, Feller JA, Hewett TE, Webster KE. Psychological Readiness to Return to Sport Is Associated With Second Anterior Cruciate Ligament Injuries. Am J Sports Med. 2019 Mar;47(4):857-862. doi: 10.1177/0363546518825258. Epub 2019 Feb 12.
PubMed 30753794Milewski MD, Traver JL, Coene RP, Williams K, Sugimoto D, Kramer DE, Kocher MS, Micheli LJ, Yen YM, Christino MA. Effect of Age and Sex on Psychological Readiness and Patient-Reported Outcomes 6 Months After Primary ACL Reconstruction. Orthop J Sports Med. 2023 Jun 9;11(6):23259671231166012. doi: 10.1177/23259671231166012. eCollection 2023 Jun.
PubMed 37332533Linver MR, Roth JL, Brooks-Gunn J. Patterns of adolescents' participation in organized activities: are sports best when combined with other activities? Dev Psychol. 2009 Mar;45(2):354-67. doi: 10.1037/a0014133.
PubMed 19271824Hansen DML, R.W.; Dworkin, J.B.;. What Adolescents Learn in Organized Youth Activities: A Survey of Self-Reported Developmental Experiences. J of Research on Adolescence. 2003;13(1):25-55.
Eime RM, Young JA, Harvey JT, Charity MJ, Payne WR. A systematic review of the psychological and social benefits of participation in sport for children and adolescents: informing development of a conceptual model of health through sport. Int J Behav Nutr Phys Act. 2013 Aug 15;10:98. doi: 10.1186/1479-5868-10-98.
PubMed 23945179Christino MA, Coene RP, Williams KA, Daley M, Ackerman KE, Stracciolini A, Kramer DE. Athletic Identity Associations in Young Sports Medicine Patients. J Am Acad Orthop Surg Glob Res Rev. 2024 Sep 16;8(9):e24.00195. doi: 10.5435/JAAOSGlobal-D-24-00195. eCollection 2024 Sep 1.
PubMed 39284016Wright RW, Dunn WR, Amendola A, Andrish JT, Bergfeld J, Kaeding CC, Marx RG, McCarty EC, Parker RD, Wolcott M, Wolf BR, Spindler KP. Risk of tearing the intact anterior cruciate ligament in the contralateral knee and rupturing the anterior cruciate ligament graft during the first 2 years after anterior cruciate ligament reconstruction: a prospective MOON cohort study. Am J Sports Med. 2007 Jul;35(7):1131-4. doi: 10.1177/0363546507301318. Epub 2007 Apr 23.
PubMed 17452511Webster KE, Feller JA, Leigh WB, Richmond AK. Younger patients are at increased risk for graft rupture and contralateral injury after anterior cruciate ligament reconstruction. Am J Sports Med. 2014 Mar;42(3):641-7. doi: 10.1177/0363546513517540. Epub 2014 Jan 22.
PubMed 24451111Wiggins AJ, Grandhi RK, Schneider DK, Stanfield D, Webster KE, Myer GD. Risk of Secondary Injury in Younger Athletes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2016 Jul;44(7):1861-76. doi: 10.1177/0363546515621554. Epub 2016 Jan 15.
PubMed 26772611Ardern CL, Webster KE, Taylor NF, Feller JA. Return to the preinjury level of competitive sport after anterior cruciate ligament reconstruction surgery: two-thirds of patients have not returned by 12 months after surgery. Am J Sports Med. 2011 Mar;39(3):538-43. doi: 10.1177/0363546510384798. Epub 2010 Nov 23.
PubMed 21098818Ardern CL, Osterberg A, Tagesson S, Gauffin H, Webster KE, Kvist J. The impact of psychological readiness to return to sport and recreational activities after anterior cruciate ligament reconstruction. Br J Sports Med. 2014 Dec;48(22):1613-9. doi: 10.1136/bjsports-2014-093842. Epub 2014 Oct 7.
PubMed 25293342Birrer D, Morgan G. Psychological skills training as a way to enhance an athlete's performance in high-intensity sports. Scand J Med Sci Sports. 2010 Oct;20 Suppl 2:78-87. doi: 10.1111/j.1600-0838.2010.01188.x.
PubMed 20840565Weiss M, Buttner M, Richlan F. The Role of Sport Psychology in Injury Prevention and Rehabilitation in Junior Athletes. Behav Sci (Basel). 2024 Mar 20;14(3):254. doi: 10.3390/bs14030254.
PubMed 38540557
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readiness Outcomes Affecting Return to Sport 3.0
- ClinicalTrials.gov ID
- NCT07476430
- Acronym / sponsor ID
- ROAR 3 / IRB-P00052897
- Conditions
- ACL Reconstruction
- Keywords
- psychological readiness, mental skills training, pediatric, adolescent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 17 Mar 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 primary aim is to determine if MST will improve coping skills in young athletes returning to sport after ACLR as measured by ACSI-28. Participants will undergo MST led by masters-level mental skills specialist pre-operatively, 3 months, 6 months, and 9 months post-operatively. Power analysis suggested at least 52 pairs are needed (α=0.05, β=0.80). There will be 65 patients enrolled in both the MST group and the control group (no MST) for a total of 130 patients. This will allow for a 4-point difference in ACSI and a 20% dropout rate.
The secondary aim is to determine if MST will improve psychological readiness and athletic identity as well as decrease psychological stress, anxiety, depression, and PTSD symptoms of young athletes returning to sport after ACLR as measured by ACL-RSI, AIMS, PROMIS-PSE, GAD-7, PHQ-9, and CRIES, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One cohort will receive mental skills training. The other cohort will not receive mental skills training.
| Arm | Type | Receives |
|---|---|---|
| Mental Skills Training (MST) Cohort | Experimental | Behavioral: Mental Skills Training (MST)This group will receive MST. The enrollment will be randomized by the treating surgeon. |
| Non-MST Cohort | No intervention | –This cohort will not receive mental skills training. The enrollment will be randomized by treating surgeon. |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosis of a complete ACL tear
- Undergoing ACL reconstruction at Boston Children's Hospital by a study-participating surgeon
- Age at time of surgery between 8 and <=25
- English-speaking patient
Key exclusion criteria (4 listed)
- Previous ACL tear
- Torn MCL, LCL, or PCL that require reconstruction in addition to ACL
- Non-English speaking patient/family
- Lack of intention to return to sports/sporting activities
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 |
|---|---|---|
| Mental Skills Training (MST)Mental skills training aims to enhance coping strategies, motivation, and confidence. MST has been identified as a potential way to improve an athlete's psychological readiness both prior to injury a | Behavioural | Mental Skills Training (MST) Cohort |
Primary outcome
Athletic Coping Skills Inventory (ACSI-28)
Time frame: The ACSI-28 will be administered preoperatively (baseline) and 9 months, 1 year, and 2 years post operatively.
A questionnaire to assess the psychological skills and coping strategies employed by athletes. Scored on a 28-point scale, where higher scores indicate a greater ability to cope.
8 secondary outcomes
The Anterior Cruciate Ligament Return to Sport after Injury Scale (ACL-RSI)
Time frame: The ACL-RSI will be administered preoperatively (baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively.
The Hospital for Special Surgery Pediatric Functional Activity Brief Scale (HSS Pedi-FABS)
Time frame: The Pedi-FABS will be assessed at baseline, 6 months, 9 months, 1 year, and 2 years
PROMIS Psychological Stress Experiences (PROMIS-PSE)
Time frame: The PROMIS-PSE will be assessed at baseline, 3 months, 6 months, 9 months, 1 year, and 2 years.
Child Revised Impact of Events Scale (CRIES)
Time frame: The CRIES will be administered preoperatively (baseline), 3 months, and 6 months.
General Anxiety Disorder-7 (GAD-7)
Time frame: The GAD-7 will be administered preoperatively (baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: The PHQ-9 will be administered preoperatively (baseline) and at 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively.
Athletic Identity Measurement Scale (AIMS)
Time frame: The AIMS will be administered preoperatively (baseline) and at 1 year and 2 years postoperatively.
International Knee Documentation Committee (IKDC) or the Pedi-IKDC
Time frame: The Pedi-IKDC will be administered preoperatively (baseline) and at 6 months, 9 months, 1 year, and 2 years postoperatively.
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 Mar 2026.
- Results publication: PubMed 38014800Griffith K, O'Brien K, McGurty S, Miller P, Christino MA. The Efficacy of a Mental Skills Training Course for Collegiate Athletes. J Athl Train. 2024 Jul 1;59(7):772-778. doi: 10.4085/1062-6050-0533.22.
- Results publication: PubMed 39359482Mercurio AM, Scott EJ, Sugimoto D, Christino MA, Coene RP, Gossman EC, Cook DL, Kocher MS, Kramer DE, Yen YM, Micheli LJ, Milewski MD. Assessing the Impact of Psychological Readiness on Performance and Symmetry in Functional Testing After ACL Reconstruction in Pediatric and Adolescent Patients. Orthop J Sports Med. 2024 Sep 27;12(9):23259671241274768. doi: 10.1177/23259671241274768. eCollection 2024 Sep.
- Results publication: PubMed 30753794McPherson AL, Feller JA, Hewett TE, Webster KE. Psychological Readiness to Return to Sport Is Associated With Second Anterior Cruciate Ligament Injuries. Am J Sports Med. 2019 Mar;47(4):857-862. doi: 10.1177/0363546518825258. Epub 2019 Feb 12.
- Results publication: PubMed 37332533Milewski MD, Traver JL, Coene RP, Williams K, Sugimoto D, Kramer DE, Kocher MS, Micheli LJ, Yen YM, Christino MA. Effect of Age and Sex on Psychological Readiness and Patient-Reported Outcomes 6 Months After Primary ACL Reconstruction. Orthop J Sports Med. 2023 Jun 9;11(6):23259671231166012. doi: 10.1177/23259671231166012. eCollection 2023 Jun.
- Results publication: PubMed 19271824Linver MR, Roth JL, Brooks-Gunn J. Patterns of adolescents' participation in organized activities: are sports best when combined with other activities? Dev Psychol. 2009 Mar;45(2):354-67. doi: 10.1037/a0014133.
- Results publicationHansen DML, R.W.; Dworkin, J.B.;. What Adolescents Learn in Organized Youth Activities: A Survey of Self-Reported Developmental Experiences. J of Research on Adolescence. 2003;13(1):25-55.
- Results publication: PubMed 23945179Eime RM, Young JA, Harvey JT, Charity MJ, Payne WR. A systematic review of the psychological and social benefits of participation in sport for children and adolescents: informing development of a conceptual model of health through sport. Int J Behav Nutr Phys Act. 2013 Aug 15;10:98. doi: 10.1186/1479-5868-10-98.
- Results publication: PubMed 39284016Christino MA, Coene RP, Williams KA, Daley M, Ackerman KE, Stracciolini A, Kramer DE. Athletic Identity Associations in Young Sports Medicine Patients. J Am Acad Orthop Surg Glob Res Rev. 2024 Sep 16;8(9):e24.00195. doi: 10.5435/JAAOSGlobal-D-24-00195. eCollection 2024 Sep 1.
- Results publication: PubMed 17452511Wright RW, Dunn WR, Amendola A, Andrish JT, Bergfeld J, Kaeding CC, Marx RG, McCarty EC, Parker RD, Wolcott M, Wolf BR, Spindler KP. Risk of tearing the intact anterior cruciate ligament in the contralateral knee and rupturing the anterior cruciate ligament graft during the first 2 years after anterior cruciate ligament reconstruction: a prospective MOON cohort study. Am J Sports Med. 2007 Jul;35(7):1131-4. doi: 10.1177/0363546507301318. Epub 2007 Apr 23.
- Results publication: PubMed 24451111Webster KE, Feller JA, Leigh WB, Richmond AK. Younger patients are at increased risk for graft rupture and contralateral injury after anterior cruciate ligament reconstruction. Am J Sports Med. 2014 Mar;42(3):641-7. doi: 10.1177/0363546513517540. Epub 2014 Jan 22.
- Results publication: PubMed 26772611Wiggins AJ, Grandhi RK, Schneider DK, Stanfield D, Webster KE, Myer GD. Risk of Secondary Injury in Younger Athletes After Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2016 Jul;44(7):1861-76. doi: 10.1177/0363546515621554. Epub 2016 Jan 15.
- Results publication: PubMed 21098818Ardern CL, Webster KE, Taylor NF, Feller JA. Return to the preinjury level of competitive sport after anterior cruciate ligament reconstruction surgery: two-thirds of patients have not returned by 12 months after surgery. Am J Sports Med. 2011 Mar;39(3):538-43. doi: 10.1177/0363546510384798. Epub 2010 Nov 23.
- Individual participant dataSharing planned: Yes. All IPD that will be shared will be de-identified and for manuscript and publishing purposes only. PHI data will not be accessible outside of the research team, and only de-identified data will be a part of the manuscript.
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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.
Dai M Sugimoto, PhD contact
Matthew D Milewski, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Skills Training (MST) in people with ACL Reconstruction, run by Boston Children's Hospital 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 4 inclusion and 4 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 Mar 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 Angelina M Sala, BS (720-340-6205, angie.sala@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Athletic Coping Skills Inventory (ACSI-28) (time frame: The ACSI-28 will be administered preoperatively (baseline) and 9 months, 1 year, and 2 years post operatively.). 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 NCT07476430, which also lists 22 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 Mar 2026.