NCT05273463

Brief Summary

The purpose of this research is to find out whether the way information about surgery is presented to patients affects patient satisfaction, knowledge retention, and surgical outcomes such as anxiety

Trial Health

75
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress94%
Aug 2022Aug 2026

First Submitted

Initial submission to the registry

February 24, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

August 23, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

February 24, 2022

Last Update Submit

April 7, 2026

Conditions

Keywords

ACL Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    Measured using the Leiden Perioperative Patient Satisfaction Questionnaire. Self-reported questionnaire that rates the subjects satisfaction with information provision, discomfort and needs during perioperative care.

    24 months

Secondary Outcomes (11)

  • Anxiety

    24 months

  • Self-Efficacy

    24 months

  • Kinesiophobia

    24 months

  • Physical Function

    24 months

  • Knowledge Retention

    24 months

  • +6 more secondary outcomes

Study Arms (3)

Video-Based Education Group

EXPERIMENTAL

Approximately 4 weeks before scheduled surgery, participants will receive the video-based intervention regarding pre-and postoperative care for ACL reconstruction.

Behavioral: Video-Based Intervention

Virtual Classroom Course Group

EXPERIMENTAL

Approximately 4 weeks before scheduled surgery, participants will receive the classroom-based intervention regarding pre-and postoperative care for ACL reconstruction.

Behavioral: Classroom-Based Intervention

Standard of Care Group

NO INTERVENTION

Participants will receive verbal and written pre-and postoperative instruction as typically received by all ACL reconstruction patients treated by the attending physicians before and after surgery.

Interventions

15-minute video about what to expect before, during, and after your surgery

Video-Based Education Group

Virtual 30-minute course with an Orthopedic nurse about what to expect before, during, and after your surgery

Virtual Classroom Course Group

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of Senior Attending orthopedic sports medicine surgeons at Mayo Clinic Arizona
  • Patients with a proficiency in English in order to participate without need for translator.
  • Patients with a diagnosis of a primary ACL injury in need of surgical reconstruction utilizing any surgical technique for ACL reconstruction.

You may not qualify if:

  • Patients with a diagnosis of ACL injury in need of a surgical revision.
  • Patients who have any multi-ligamentous injuries to the knee requiring modified postoperative unloading.
  • Patients who have history of previous anterior cruciate ligament reconstructions in either leg.
  • Patients who have either auditory or visual impairments.
  • Patients who are medical professionals with work-related knowledge of ACL reconstruction.
  • Patients with an inability or unwillingness of individual or legal guardian to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Hayley Powell, MSN, RN

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 10, 2022

Study Start

August 23, 2022

Primary Completion

December 2, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations