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NCT04847258 Clinical Trial

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

Anterior Cruciate Ligament Injuries Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04847258
Other study ID # ACL screening
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 19, 2021
Est. completion date May 31, 2024

Study information
Verified date May 2023
Source Vejle Hospital
Contact Kamilla Arp, MSc
Phone +45 79406796
Email kamilla.dessau.arp@rsyd.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 532
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 49 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injuries

Intervention

Other:
• Standard rehabilitation
Patients follow standard municipal rehabilitation

Locations
Country Name City State
Denmark Vejle Hospital Vejle Region Of Southern Denmark

Sponsors (1)
Lead Sponsor Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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