Rate of Non-copers to Non-surgical ACL Treatment After 3... | NCT04847258

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

NCT04847258

Sponsor

Vejle Hospital

Status

Active, not recruiting

Last Update Posted

Jul 1, 2026Actual

Enrollment

357Estimated

Phase

Not provided

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Standard rehabilitation

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2021Actual

Primary Completion Date

Sep 30, 2026Estimated

Completion Date

Sep 30, 2027Estimated

First Submitted Date

Apr 8, 2021

First Submission Date that Met QC Criteria

Apr 14, 2021

First Posted Date

Apr 19, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2026

Last Update Posted Date

Jul 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

357Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard rehabilitation	Other	Patients follow standard municipal rehabilitation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claus Varnum, ph.d.	Vejle Hosptal	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vejle Hospital		Vejle	Region Syddanmark	7100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries

Ancestor Terms

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided