Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation

Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation - a Prospective Cohort Study

The aim is to determine the sensitivity and specificity of a screening tool to identify patients who undergo ACL reconstruction (non-copers) after 3 months of standard rehabilitation following an anterior Cruciate ligament (ACL) injury.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Other: Standard rehabilitation

Detailed Description

All included patients are referred to municipal rehabilitation to resolve effusion and range of motion deficits before the first screening (baseline screening) is completed. Hereafter the patients follow 3 months municipal rehabilitation before the second screening (3 months screening). A physiotherapist performs the screening and at the second screening, this is performed prior to consulting an orthopaedic surgeon.

• Study Type: Observational
• Enrollment (Estimated): 357

Contacts and Locations

• Study Contact: Name: Kamilla Arp, MSc; Phone Number: +45 79406796; Email: kamilla.dessau.arp@rsyd.dk
• Study Contact Backup: Name: Claus Varnum, ph.d.; Phone Number: +45 79405779; Email: claus.varnum@rsyd.dk

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Vejle, Region Of Southern Denmark, Denmark, 7100
      • Recruiting
      • Vejle Hospital
      • Contact: Kamilla Arp, MSc.; Phone Number: +4579406796; Email: kamilla.dessau.arp@rsyd.dk
      • Contact: Claus Varnum, ph.d.; Phone Number: +4579405779; Email: claus.varnum@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the outpatient clinic at the Department of Orthopaedic Surgery at Vejle Hospital, Denmark

Description

Inclusion Criteria:

• unilateral primary ACL injury
• Index injury no older than 6 months

Exclusion Criteria:

• Multiligament rupture
• Large cartillage or meniscus injuries
• Scheduled ACL reconstruction within 3 months

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients undergoing ACL reconstruction after 3 months of standard rehabilitation	Patients undergoing ACL reconstruction after 3 months of standard rehabilitation are defined as non-copers to the non-surgical treatment, which will define the sensitivity and specificity of the screening examination.	3 months

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Study Director: Claus Varnum, ph.d., Vejle Hosptal

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: ACL screening

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No