Effect of Patient Resilience on Return to Sport Post ACL... | NCT03013231

Studies
Effect of Patient Resilience on Return to Sport Post ACL Reconstruction Surgery

NCT03013231

Sponsor

St. Louis University

Status

Completed

Last Update Posted

Sep 6, 2019Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Anterior Cruciate Ligament Reconstruction

Interventions

Brief Resilience Scale

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
27659	Other Identifier	SLU IRB

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2017Actual

Primary Completion Date

Aug 30, 2019Actual

Completion Date

Aug 30, 2019Actual

First Submitted Date

Jan 4, 2017

First Submission Date that Met QC Criteria

Jan 4, 2017

First Posted Date

Jan 6, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2019

Last Update Posted Date

Sep 6, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Scott Kaar, MD, Associate Professor, Dept. of Orthopaedic Surgery, St. Louis UniversityPrincipal Investigator

Lead Sponsor

St. Louis UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Behavioral: Brief Resilience Scale

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brief Resilience Scale	Behavioral	6 months post-op, patients will complete the BRS survey as a method of evaluating resilience.	s/p ACLR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Return to Sport	Whether the patient has returned to sport s/p ACLR	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

English speaking patients
Isolated ACL tear having undergone surgical reconstruction.

Exclusion Criteria:

Non-English speaking patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

English speaking patients 14 yrs of age or older with isolated ACL tear and having undergone surgical reconstruction.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott Kaar, MD	St. Louis University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SSM Health Saint Louis University Hospital		St Louis	Missouri	63110	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18696313	Background	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.