NCT02115451

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

6.4 years

First QC Date

April 14, 2014

Last Update Submit

April 24, 2014

Conditions

Anterior Cruciate Ligament Injury

Outcome Measures

Primary Outcomes (1)

  • Patient-reported knee function (IKDC 2000)

    2 years

Secondary Outcomes (3)

  • Isokinetic knee extensor and flexor muscle strength

    2 years

  • Knee reinjury

    2 years

  • Participation in level I, II and III sports

    2 years

Study Arms (2)

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

Eligibility Criteria

Age13 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Athletically active anterior cruciate ligament injured patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NAR- Department of Orthopaedics, Oslo University Hospital & Nimi

Oslo, Oslo County, 0407, Norway

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • May Arna Risberg, PT PhD

    Norwegian Research Center for Active Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 16, 2014

Study Start

January 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

NO(1)