NCT05533489

Brief Summary

In 2006, approximately 130,000 arthroscopic anterior cruciate ligament reconstructions were performed in the United States, and the number is increasing each year. Despite being a minimally invasive procedure, pain is the most common postoperative problem after arthroscopic anterior cruciate ligament reconstruction associated with cost, postoperative opioid consumption, opioid-related side effects, quality of life, patient satisfaction, and delayed discharge. Over two-thirds of the patient receiving arthroscopic anterior cruciate ligament surgery have moderate to severe pain.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
924

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

September 5, 2022

Last Update Submit

September 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • To find risk factors for moderate to severe postoperative pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours.

    To find risk factors for moderate to severe postoperative pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours

    Three days

Secondary Outcomes (2)

  • To find incidence of moderate to severe pain after arthroscopic anterior cruciate ligament reconstruction in the first 72 hours

    Three days

  • To find analgesic requirement after arthroscopic anterior cruciate ligament reconstruction for 1 year

    One year after discharge

Interventions

No intervention This study is a retrospective descriptive study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing primary unilateral arthroscopic anterior cruciate ligament reconstruction with or without unilateral cartilage/meniscus injury with or without other ligaments injury (posterior cruciate ligament/medial collateral ligament/lateral collateral ligament)

Patients undergoing primary unilateral arthroscopic anterior cruciate ligament reconstruction with or without unilateral cartilage/meniscus injury with or without other ligaments injury (posterior cruciate ligament/medial collateral ligament/lateral collateral ligament) Age ≥ 15 years

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 9, 2022

Study Start

October 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

September 9, 2022

Record last verified: 2022-09