Nonsurgical or Surgical Treatment of ACL Injuries | NCT02115451

Studies
Nonsurgical or Surgical Treatment of ACL Injuries

NCT02115451

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Apr 25, 2014Estimated

Enrollment

143Actual

Phase

Not provided

Conditions

Anterior Cruciate Ligament Injury

Interventions

Not provided

Countries

Norway

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Apr 14, 2014

First Submission Date that Met QC Criteria

Apr 14, 2014

First Posted Date

Apr 16, 2014Estimated

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

Apr 24, 2014

Last Update Posted Date

Apr 25, 2014Estimated

Name	Class
University of Delaware	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 of this study is to evaluate knee function, sports participation and knee reinjuries over 2 years in a group of patients who choose either nonsurgical or surgical treatment for an anterior cruciate ligament (ACL) injury

Detailed Description

This study is a part study of an overall study with the title 'Dynamic stability of the ACL-injured knee'. The overall study prospectively follows a cohort of newly injured patients with total rupture of the anterior cruciate ligament in the knee.

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

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical treatment		Patients who undergo rehabilitation and anterior cruciate ligament reconstruction, other surgical interventions may be performed
Nonsurgical treatment		Patients who undergo rehabilitation without anterior cruciate ligament reconstruction, other surgical interventions may be performed

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient-reported knee function (IKDC 2000)		2 years

Secondary Outcomes

Measure	Description	Time Frame
Isokinetic knee extensor and flexor muscle strength		2 years
Knee reinjury		2 years
Participation in level I, II and III sports

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anterior cruciate ligament rupture within 3 months of injury
Preinjury participation in level I or II sports at least twice a week

Exclusion Criteria:

Current or previous injury to the contralateral leg
Another grade III ligament injury, fracture, full-thickness articular cartilage damage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Athletically active anterior cruciate ligament injured patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
May Arna Risberg, PT PhD	Norwegian Research Center for Active Rehabilitation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NAR- Department of Orthopaedics, Oslo University Hospital & Nimi		Oslo	Oslo	0407	Norway

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