Anterior Cruciate Ligament ReconstructionNCT03013231
Effect of Patient Resilience on Return to Sport Post ACL Reconstruction Surgery
An observational study of Anterior Cruciate Ligament Reconstruction, run by St. Louis University at 1 site in United States.
Trial summary
Despite the large majority of patients that undergo ACL reconstruction reporting successful outcomes in regard to tests of knee function, only about 2/3 return to their prior level or athletic activity after surgery. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Brief Resilience Scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2017to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: English speaking patients 14 yrs of age or older with isolated ACL tear and having undergone surgical reconstruction.
Who may be able to join
- English speaking patients
- Isolated ACL tear having undergone surgical reconstruction.
Who cannot join
- Non-English speaking patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63110
About this study
Despite the large majority of patients that undergo ACL reconstruction reporting successful outcomes in regard to tests of knee function, only about 2/3 return to their prior level or athletic activity after surgery. A large amount of research has been conducted investigating the effects of psychological factors on return to sports after ACL reconstruction; however, the specific role of resilience has yet to be solely analyzed. This study aims to determine the effect of variations in patient resilience on their return to sports after surgery.
Read the detailed description
Meta-analysis of post ACL reconstruction return to sport suggests that despite approximately 90% of patients achieving successful outcomes in terms of objectively measurable knee function, only 63% return to their pre-injury sport participation rate. This leads one to question what factors other than knee function may contribute to such a discrepancy. Prior studies have shown psychological factors, such as fear of re-injury, can play in role in whether a patient returns to play. However, the role of patient resilience on recovery is less clear. This research will examine the effect of patient resilience on post-ACLR return to sport. The Brief Resiliency Scale (BRS), a proven method of assessing ability to recover from stressful situations, will be used to evaluate patient resilience. The role of resilience on recovery post shoulder surgery, as well as rehabilitation in post-operative orthopaedic geriatric patients has been examined; however, the effect of resilience on specifically ACLR return to sport has yet to be studied.
This research will provide insight as to how to identify patients at high risk for not returning to sport, the first step in improving return to sport outcomes in ACL reconstruction patients.
- Being tested
- Brief Resilience Scale
- Keywords
- ACL Reconstruction, Return to Sport, Resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Resilience ScaleBehavioural
Also called BRS
6 months post-op, patients will complete the BRS survey as a method of evaluating resilience.
| Study group | Role | What they receive |
|---|---|---|
| s/p ACLR | Patients having undergone ACL Reconstruction Surgery with goal of returning to sport. 6 months post-op, patients will complete the BRS survey as a method of evaluating resilience. Receives: Behavioral: Brief Resilience Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to Sport
Whether the patient has returned to sport s/p ACLR
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 posted6 Jan 2017 (estimated)
- Study start20 Jan 2017
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Kaar, MD, St. Louis University
- Investigators
- Scott Kaar, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013231
- Sponsor's protocol ID
- 47659
- Other IDs
- 27659
- Status last verified
- Sep 2019
- First submitted
- 4 Jan 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
PubMed 18696313
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Resilience on Return to Sport Post ACL Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT03013231
- Acronym / sponsor ID
- 47659
- Keywords
- ACL Reconstruction, Return to Sport, Resilience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
Despite the large majority of patients that undergo ACL reconstruction reporting successful outcomes in regard to tests of knee function, only about 2/3 return to their prior level or athletic activity after surgery. A large amount of research has been conducted investigating the effects of psychological factors on return to sports after ACL reconstruction; however, the specific role of resilience has yet to be solely analyzed. This study aims to determine the effect of variations in patient resilience on their return to sports after surgery.
Detailed description
Meta-analysis of post ACL reconstruction return to sport suggests that despite approximately 90% of patients achieving successful outcomes in terms of objectively measurable knee function, only 63% return to their pre-injury sport participation rate. This leads one to question what factors other than knee function may contribute to such a discrepancy. Prior studies have shown psychological factors, such as fear of re-injury, can play in role in whether a patient returns to play. However, the role of patient resilience on recovery is less clear. This research will examine the effect of patient resilience on post-ACLR return to sport. The Brief Resiliency Scale (BRS), a proven method of assessing ability to recover from stressful situations, will be used to evaluate patient resilience. The role of resilience on recovery post shoulder surgery, as well as rehabilitation in post-operative orthopaedic geriatric patients has been examined; however, the effect of resilience on specifically ACLR return to sport has yet to be studied.
This research will provide insight as to how to identify patients at high risk for not returning to sport, the first step in improving return to sport outcomes in ACL reconstruction patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| s/p ACLR | – | Behavioral: Brief Resilience ScalePatients having undergone ACL Reconstruction Surgery with goal of returning to sport. 6 months post-op, patients will complete the BRS survey as a method of evaluating resilience. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- English speaking patients 14 yrs of age or older with isolated ACL tear and having undergone surgical reconstruction.
Key inclusion criteria (2 listed)
- English speaking patients
- Isolated ACL tear having undergone surgical reconstruction.
Key exclusion criteria (1 listed)
- Non-English speaking patients.
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 |
|---|---|---|
| Brief Resilience ScaleAlso: BRS6 months post-op, patients will complete the BRS survey as a method of evaluating resilience. | Behavioural | s/p ACLR |
Primary outcome
Return to Sport
Time frame: 1 year
Whether the patient has returned to sport s/p ACLR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Background: PubMed 18696313Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Reconstruction
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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. This study is not recruiting at the moment.
Scott Kaar, MD principal investigator
St. Louis University
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 Reconstruction, run by St. Louis University 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 6 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to Sport (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 NCT03013231, which also lists 1 linked publication.
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 6 Sep 2019.