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Long-term Follow-up of Anterior Cruciate Ligament Injury (ACLLTFU)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Joanna Kvist, Linkoeping University
Sponsor:
Information provided by (Responsible Party):
Joanna Kvist, Linkoeping University
ClinicalTrials.gov Identifier:
NCT03182647
First received: June 5, 2017
Last updated: June 30, 2017
Last verified: June 2017
  Purpose

Anterior cruciate ligament (ACL) rupture is one of the most common sports-related knee injuries. Because it is such a significant injury - requiring a long period of rehabilitation before the injured person is ready to return to physical activity, the burden of injury is high. This can help to explain why so much of orthopaedic research is devoted to evaluating the outcomes of ACL injury. However, while there has been extensive study of short-term (up to 5 years after injury) outcomes, few studies have followed patients beyond 15 years after their ACL injury. This is important because long-term follow-up can provide key insights to guide the information provided to newly injured patients (e.g. to help set realistic expectations of what the injured person can expect of their knee function in the future), and help us evaluate the efficacy of previous treatments.

The primary aim is to assess the influence of an acute ACL injury on knee function and quality of life, 32-37 years after the index injury. Approximately 300 patients injured between 1980 and 1985 will be invited to participate in the study. Patient- and clinician-reported outcomes, and radiographic osteoarthritis will be evaluated.


Condition Intervention
Anterior Cruciate Ligament Injury Procedure: Surgically treatment of the ACL Other: Non surgical initial ACL treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Follow-up of Anterior Cruciate Ligament Injury

Further study details as provided by Joanna Kvist, Linkoeping University:

Primary Outcome Measures:
  • Self reported knee function [ Time Frame: 32-37 years after ACL injury ]
    Knee Injury and Osteoarthritis Outcome Score, KOOS 4 (Pain, Symptoms, Sport/Rec, QOL subscales)

  • Osteoarthritis [ Time Frame: 32-37 years after ACL injury ]
    Development of osteoarthritis examined with tibiofemoral and patellofemoral radiographs


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 32-37 years after ACL injury ]
    ACL-Quality of Life scale (ACL-QoL)

  • Physical activity [ Time Frame: 32-37 years after ACL injury ]
    Total time over the previous week spent doing moderate, and vigorous activity AND accelerometer measures

  • Objective assessment of knee function [ Time Frame: 32-37 years after ACL injury ]
    Concentric isokinetic muscle strength

  • Objective assessment of knee function [ Time Frame: 32-37 years after ACL injury ]
    Functional testing; stand-up test

  • Objective assessment of knee function [ Time Frame: 32-37 years after ACL injury ]
    Functional testing; hopping performance in one leg hop for distance

  • Objective assessment of knee function [ Time Frame: 32-37 years after ACL injury ]
    Postural control (one leg stand test)

  • Associated injuries and additional surgery [ Time Frame: 32-37 years after ACL injury ]
    Patient reported


Estimated Enrollment: 300
Actual Study Start Date: June 9, 2017
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non surgery
Patients were not treated with surgery initially
Other: Non surgical initial ACL treatment
Non surgical initial ACL treatment
Surgery
Patients had an initial surgical treatment
Procedure: Surgically treatment of the ACL
Surgical initial ACL treatment

Detailed Description:

Patients injuring their ACL between 1980 and 1985 have periodically been followed since the injury. Now, we plan to contact all patients and invite them to participate. The patients will be asked to

  1. complete a questionnaire battery
  2. visit the movement laboratory at Linköping University for an objective assessment of knee function and
  3. have an x-ray of both knee joints.

Baseline information including associated injuries, treatment and activity level exist for all the patients. At that time, rehabilitation was normally completed after 4-6 months for non-operatively treated patients, and nine months after ACL surgery.

  Eligibility

Ages Eligible for Study:   47 Years to 77 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Baseline data from the time for injury were collected consequently. The initial 167 patients were included in a randomised clinical trial of surgical vs. non-surgical treatment and the following patients were treated according to common practise at that time.
Criteria

Inclusion Criteria:

  • primary ACL injury between 1980 and 1985, age between 15 and 40 at injury

Exclusion Criteria:

  • all patients from the initial cohort will be invited for participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03182647

Contacts
Contact: Joanna Kvist, Professor +4613284664 joanna.kvist@liu.se

Locations
Sweden
Linkoping University Recruiting
Linkoping, Ostergotland, Sweden, 58183
Contact: Joanna Kvist, Professor    +46 (0) 13 284664    joanna.kvist@liu.se   
Principal Investigator: Joanna Kvist, Professor         
Sponsors and Collaborators
Linkoeping University
Investigators
Principal Investigator: Joanna Kvist, Professor IMH Linkoping University, Sweden
  More Information

Publications:
Responsible Party: Joanna Kvist, Professor, Linkoeping University
ClinicalTrials.gov Identifier: NCT03182647     History of Changes
Other Study ID Numbers: ACL LTFU
Study First Received: June 5, 2017
Last Updated: June 30, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 18, 2017