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

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries

• Registration Number: NCT04847258
• Lead Sponsor: Vejle Hospital

Brief 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.

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 Timeline

• Study Start: 2021-03-19
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-19
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-17
• Last Update Posted: 2025-06-24
• Primary Completion: 2027-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 357

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients undergoing ACL reconstruction after 3 months of standard rehabilitation	3 months	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.

Trial Locations

Locations (1)

Vejle Hospital; 🇩🇰 Vejle, Region Of Southern Denmark, Denmark